H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
FDA 510(k) clearance K961752 · decided 1996-08-08
Clearance details
- K-number
- K961752
- Device name
- H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
- Applicant
- Ackrad Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1996-05-06
- Decision date
- 1996-08-08
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cranford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hyste recall (Z-0502-2024) | CooperSurgical, Inc. | 2023-12-06 |
| Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610 recall (Z-1613-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |