CURITY FAST-CATH FEMALE CATHETER KIT
FDA 510(k) clearance K935774 · decided 1994-04-11
Clearance details
- K-number
- K935774
- Device name
- CURITY FAST-CATH FEMALE CATHETER KIT
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Decision
- Unknown
- Date received
- 1993-12-03
- Decision date
- 1994-04-11
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- EYT
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, 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 |
|---|---|---|
| URINARY DRAINAGE BAG (K934080) | Kit Pak, Inc. | 1994-05-18 |
| COMFORT CATH MALE EXTERNAL CATHETER (K883057) | Sierra Laboratories, Inc. | 1988-08-02 |
| VPI NON-ADHESIVE CONDOM CATHETER (K883119) | Cook Urological, Inc. | 1988-08-02 |
Recalls involving this device
No recalls on record reference this clearance.