Percutaneous Draining Catheter
FDA 510(k) K811378 · Medi-Tech, Inc.
510(k) numberK811378
Submission
- Device name
- Percutaneous Draining Catheter
- Applicant
- Medi-Tech, Inc.
Walker, MI, US - Received
- May 15, 1981
- Decision date
- June 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBW – Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBW
| 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 |
More from Helix Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | 05/15/1996SE |
| K952345 | Medi-Tech Platform Guide CatheterDQY · Traditional | 08/17/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | 12/13/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was Percutaneous Draining Catheter cleared by the FDA?
Percutaneous Draining Catheter (K811378) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 18 days after the submission was received.
What is the product code of K811378?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.