USCI SUPER 9 PTCA GUIDING CATHETER
FDA 510(k) clearance K922541 · decided 1992-12-08
Clearance details
- K-number
- K922541
- Device name
- USCI SUPER 9 PTCA GUIDING CATHETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-29
- Decision date
- 1992-12-08
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- DQI
- Device class
- 2
- Regulation number
- 870.1800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KSEA MODEL 383320 20 ANGIOMAT (K960486) | Karl Storz Endoscopy | 1996-10-25 |
| SURGIPUMP (K935763) | W.O.M. World of Medicine GmbH | 1994-04-21 |
| LEOCOR CORFLO PUMP -- MODIFICATION (K924110) | Leocor, Inc. | 1992-09-01 |
| BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (K905189) | Baxter Healthcare Corp | 1991-01-30 |
| CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (K902444) | Intramed Laboratories, Inc. | 1990-08-30 |
| NOBLES-LAI ENGINEERING INFUSION PUMP (K895688) | Nobles-Lai Engineering, Inc. | 1990-02-26 |
| ANGIOSCOPY PUMP (K895074) | Baxter Healthcare Corp | 1990-01-31 |
| OLYMPUS ANGIOSCOPY PUMP (K871422) | Olympus Corp. | 1987-08-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |