UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
FDA 510(k) clearance K140085 · decided 2014-11-18
Clearance details
- K-number
- K140085
- Device name
- UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2014-01-13
- Decision date
- 2014-11-18
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- FEW
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bloomington, IN, 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 |
|---|---|---|
| BARD MALECOT AND PEZZER DRAINS (K070879) | C.R. Bard, Inc. | 2007-04-24 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K981258) | Medical Device Technologies, Inc. | 1998-04-22 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K954147) | Manan Medical Products, Inc. | 1996-03-26 |
| SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (K954116) | Technical Products, Inc. | 1995-11-06 |
| OLYMPIC SMART SCALE CARE CENTER (K920423) | Olympic Medical Corp. | 1992-06-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |