PERCUTANEOUS DRAINING CATHETER
FDA 510(k) clearance K811378 · decided 1981-06-02
Clearance details
- K-number
- K811378
- Device name
- PERCUTANEOUS DRAINING CATHETER
- Applicant
- Medi-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-15
- Decision date
- 1981-06-02
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- GBW
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MINI-PORT (K992904) | Taut, Inc. | 1999-10-05 |
| INTRADUCER (K992907) | Taut, Inc. | 1999-10-05 |
| INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (K972112) | Taut, Inc. | 1997-12-01 |
| ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (K961194) | Sil-Med Corp. | 1996-08-08 |
| MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (K960426) | Medical Components, Inc. | 1996-03-21 |
| MEDIASTINAL SILICONE DRAINS (K942709) | Sil-Med Corp. | 1996-01-04 |
| ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER (K933510) | Sherwood Medical Co. | 1994-02-24 |
| BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (K926477) | Core Dynamics, Inc. | 1993-11-12 |
| STERILE CHEST TUBE (K913733) | Vascular Products, Inc. | 1991-10-08 |
| HOUTS HYSTERECTOMY DRAIN (K894220) | Helix Medical, Inc. | 1989-08-24 |
| MADEGOM LTDA. PENROSE DRAIN TUBING (K894119) | Madegom | 1989-08-18 |
| NELSON-JUNG PLEURAL CATH (K854812) | Research Medical, Inc. | 1986-02-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1334-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1335-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1336-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1338-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneou recall (Z-1499-06) | Boston Scientific Corp | 2006-09-13 |