HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
FDA 510(k) clearance K033477 · decided 2004-06-10
Clearance details
- K-number
- K033477
- Device name
- HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- Applicant
- Rochester Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-03
- Decision date
- 2004-06-10
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- MJC
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stewartville, MN, US
- Third-party review
- No
- Expedited review
- No
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| BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101) | C.R. Bard, Inc. | 1998-11-03 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 recall (Z-0198-2016) | C.R. Bard, Inc. | 2015-11-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMSOFT URETHRAL INSERT (P990002/S002) | Rochester Medical Corp. | 2013-03-21 |
| FEMSOFT URETHRAL INSERT (P990002/S001) | Rochester Medical Corp. | 2000-12-28 |
| FEMSOFT URETHRAL INSERT (P990002) | Rochester Medical Corp. | 1999-09-30 |