BARD HYSTEROSALPINGOGRAPHY CATHETERS
FDA 510(k) clearance K890869 · decided 1989-04-25
Clearance details
- K-number
- K890869
- Device name
- BARD HYSTEROSALPINGOGRAPHY CATHETERS
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-21
- Decision date
- 1989-04-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HES
- Device class
- 2
- Regulation number
- 884.1300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Billerica, MA, 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 |
|---|---|---|
| KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (K140761) | Carefusion 2200, Inc. | 2014-04-21 |
| HYSTALOG HSG CATHETER (K000340) | Rocket Medical Plc | 2000-04-19 |
| MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (K903209) | Adler Instrument Co. | 1990-12-21 |
| MAXI-FLOW INSUFFLATOR TUBING SET (K903208) | Adler Instrument Co. | 1990-12-17 |
| KRONNER MANIPUJECTOR (K904473) | Unimar, Inc. | 1990-12-14 |
| CORE DISPOSABLE INSUFFLATION TUBING (K901413) | Core Dynamics, Inc. | 1990-09-24 |
| SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER (K891290) | Cook Ob/Gyn | 1989-05-23 |
| LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (K875137) | F.M. Wiest USA, Inc. | 1988-03-02 |
| UTERINE INJECTOR 2MM (K873515) | Zinnanti Surgical Instruments, Inc. | 1987-09-29 |
| CABOT MEDICAL VARIABLE FLOW INSUFFLATOR (K862310) | Cabot Medical Corp. | 1986-08-12 |
| FEMTEST (K844173) | Bionexus, Inc. | 1985-08-14 |
| UTERINE INJECTOR 4.0MM (K841682) | Humi Corp. | 1984-07-03 |
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 |