Thoracic Catheter (Chest Drainage Tube)
FDA 510(k) K863142 · Sheridan Catheter Corp.
510(k) numberK863142
Submission
- Device name
- Thoracic Catheter (Chest Drainage Tube)
- Applicant
- Sheridan Catheter Corp.
Argyle, NY, US - Received
- August 15, 1986
- Decision date
- August 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBS – Catheter, Ventricular, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912645 | Atriums PDR Thoracic CatheterGBS · Traditional | Atrium Medical Corp. | 09/13/1991SE |
| K883887 | Axiom Atraum Wound DrainsGBS · Traditional | Axiom, Inc. | 02/17/1989SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | Sheridan Catheter Corp. | 05/18/1988SE |
| K880895 | Uresil Wound Drain TrocarGBS · Traditional | Uresil Corp. | 03/14/1988SE |
| K880376 | Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional | Genesis Industries, Inc. | 02/16/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | Gish Biomedical, Inc. | 10/28/1987SE |
| K872460 | AN3000 Mahoney DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/23/1987SE |
| K872459 | AN3100 Mulholland DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K872457 | AN3500 Worth DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K870015 | Hci All Purpose Drain/Catheter SetGBS · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922894 | Lazer-Trach Tracheal TubeBTR · Traditional | 05/07/1993SE |
| K897046 | Laser Resistant Tracheal TubeCBI · Traditional | 03/23/1990SE |
| K890823 | Accessory to Clinical Electronic ThermometerFLL · Traditional | 05/05/1989SE |
| K884765 | Clinical Electronic ThermometersFLL · Traditional | 02/16/1989SE |
| K882918 | Kim Naso-Intestinal TubeKNT · Traditional | 12/05/1988SE |
| K882127 | Clinical Electronic ThermometersFLL · Traditional | 08/04/1988SE |
| K881368 | Clinical Electonic ThermometersFLL · Traditional | 07/13/1988SE |
| K881293 | Sheridan Electrosurgery Protection FilterBZT · Traditional | 06/16/1988SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | 05/18/1988SE |
| K880960 | Ndyag Laser Tracheal TubeBTR · Traditional | 04/29/1988SE |
Questions and answers
When was Thoracic Catheter (Chest Drainage Tube) cleared by the FDA?
Thoracic Catheter (Chest Drainage Tube) (K863142) received a 510(k) decision of Substantially Equivalent on August 29, 1986, 14 days after the submission was received.
What is the product code of K863142?
The FDA product code is GBS – Catheter, Ventricular, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.