IRRIGATION CATHETER
FDA 510(k) clearance K780788 · decided 1978-06-22
Clearance details
- K-number
- K780788
- Device name
- IRRIGATION CATHETER
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-05-15
- Decision date
- 1978-06-22
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- GBX
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MOERAE VEIN PREPARATION KIT (K131659) | Moerae Matrix, Inc. | 2014-03-03 |
| GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) | Maquet Cardiovascular, LLC | 2008-12-17 |
| DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (K052286) | The Catheter Exchange, Inc. | 2005-10-21 |
| GRAFTSAVER (K043515) | Vescare, Inc. | 2005-03-31 |
| MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417) | Misonix, Inc. | 2002-01-10 |
| DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704) | Dmc Medical, Ltd. | 2000-05-19 |
| LYSONIX IRRIGATION SYSTEM (K974233) | Lysonix, Inc. | 1998-02-03 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146) | Axiom Medical, Inc. | 1997-03-10 |
| SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295) | Sil-Med Corp. | 1996-06-26 |
| CLOSED FLUID COLLECTION SYSTEM (K961147) | B.Braun Medical, Inc. | 1996-05-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |