SILICONE ANTIBACTERIAL FOLEY CATHETER
FDA 510(k) clearance K971627 · decided 1998-01-13
Clearance details
- K-number
- K971627
- Device name
- SILICONE ANTIBACTERIAL FOLEY CATHETER
- Applicant
- Rochester Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-02
- Decision date
- 1998-01-13
- Days to decision
- 256 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Wellead® Latex Foley Catheter (K233094) | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| BARDEX I.C. LATEX FOLEY CATHETER (K040658) | C.R. Bard, Inc. | 2004-09-29 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| SPECTRUM SILICONE FOLEY CATHETER (K000251) | Cook Urological, Inc. | 2000-08-30 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464) | C.R. Bard, Inc. | 1999-12-10 |
| BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136) | Bard Medical Div. | 1999-02-16 |
| BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101) | C.R. Bard, Inc. | 1998-11-03 |
| BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (K910318) | C.R. Bard, Inc. | 1994-08-18 |
Recalls involving this device
No recalls on record reference this clearance.
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 |