Catheter, Peritoneal
FDA product code GBW · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
17510(k) clearances
0PMA approvals
12recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992907 | IntraducerGBW · Traditional | Taut, Inc. | 10/05/1999SE |
| K992904 | Mini-PortGBW · Traditional | Taut, Inc. | 10/05/1999SE |
| K972112 | Intraducer Port SC CATALOG#31275,31035,30915, and 31450GBW · Traditional | Taut, Inc. | 12/01/1997SE |
| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | Sil-Med Corp. | 08/08/1996SE |
| K960426 | Medicomp Flexi-Smooth Wound Drainage CatheterGBW · Traditional | Medical Components, Inc. | 03/21/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | Sil-Med Corp. | 01/04/1996SN |
| K933510 | Argyle Turkel Safety Trocar Thoracic CatheterGBW · Traditional | Sherwood Medical Co. | 02/24/1994SE |
| K926477 | Bifurcated Suction/Irrigat Tubing Set W/Push ButtoGBW · Traditional | Core Dynamics, Inc. | 11/12/1993SE |
| K913733 | Sterile Chest TubeGBW · Traditional | Vascular Products, Inc. | 10/08/1991SE |
| K894220 | Houts Hysterectomy DrainGBW · Traditional | Helix Medical, Inc. | 08/24/1989SE |
| K894119 | Madegom Ltda. Penrose Drain TubingGBW · Traditional | Madegom | 08/18/1989SE |
| K854812 | Nelson-Jung Pleural CathGBW · Traditional | Research Medical, Inc. | 02/11/1986SE |
| K843575 | Derbyshire DrainGBW · Traditional | Sil-Med Corp. | 10/24/1984SE |
| K813063 | Flat DrainGBW · Traditional | Sil-Med Corp. | 12/18/1981SE |
| K811627 | Arrow Peritoneal Lavage Catherization KGBW · Traditional | Arrow Intl., Inc. | 08/10/1981SE |
| K811378 | Percutaneous Draining CatheterGBW · Traditional | Medi-Tech, Inc. | 06/02/1981SE |
| K800422 | Adt Mini Peritoneal Lavage KitGBW · Traditional | A.D.T. Lab Industries | 03/12/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2380-2026 Class I | Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1099-2018 Class II | Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-0135-2017 Class II | CORE Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0134-2017 Class II | CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0133-2017 Class II | CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0132-2017 Class II | CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0130-2017 Class II | CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0129-2017 Class II | CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags…The packaging seal may contain a crease. The crease may result in an open channel. These channels may… | ConMed Corporation | 06/27/2016Terminated |
| Z-0277-2016 Class II | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the…The defective component can cause gas leakage through the device. This can result in loss of… | Teleflex Medical | 10/14/2015Terminated |
| Z-2186-2012 Class III | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research…Product is missing the label on the internal packaging. | Teleflex Medical | 07/20/2012Terminated |
| Z-1334-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | Boston Scientific Corporation | 03/18/2009Terminated |
| Z-0428-2007 | Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal…Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the… | Taut, Inc. | 01/19/2007Terminated |