INTRAUTERINE INSEMINATION CATHETERS
FDA 510(k) clearance K896960 · decided 1990-06-26
Clearance details
- K-number
- K896960
- Device name
- INTRAUTERINE INSEMINATION CATHETERS
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-14
- Decision date
- 1990-06-26
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- HDR
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| OVES CERVICAL CAP (K993953) | Veos , Ltd. | 2000-03-21 |
| IMAGYN INTRAUTERINE INSEMINATION DEVICE (K945131) | Imagyn Medical, Inc. | 1995-05-15 |
| COOK INSEMINATION CUP (K950714) | Cook Urological, Inc. | 1995-05-11 |
| MINISPACE(TM) IUI CATHETER (K902171) | Pharmacia, Inc. | 1990-10-05 |
| COAXIAL CATHETER SET (K902694) | Cook Ob/Gyn | 1990-08-28 |
| MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (K900316) | Irvine Scientific | 1990-04-16 |
| SPERM SELECT SYSTEM (K900308) | Pharmacia, Inc. | 1990-04-13 |
| DGH A-SAN PROBE HOLDER (K900162) | Jedmed Instrument Co. | 1990-02-16 |
| MODIFIED HAM'S F-10 W/ALBUMIN (K894432) | Irvine Scientific | 1989-09-22 |
| HTF WITH ALBUMIN (CATALOG NO. 9994) (K894405) | Irvine Scientific | 1989-09-22 |
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 |