510(k) K140085
- Device
- UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
- Applicant
- COOK INCORPORATED
- 510(k) number
- K140085
- Product code
- FEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-18
- Date received
- 2014-01-13
- Regulation
- 876.5090
- Classification name
- Catheter, Malecot
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELYSIA EASTON
- Address
- 750 Daniels Way Bloomington IN US 47404 47404
FDA Registration Numbers#
- 1018233
- 9611590
- 1061771
- 8040607
- 3006082230
- 3006430057
- 1820334
- 3030446844
- 1825146
Source Documents#
Other 510(k) Records For Product Code FEW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070879 | BARD MALECOT AND PEZZER DRAINS | C.R. Bard, Inc. | 2007-04-24 |
| K981258 | MANAN MALECOT BASKET DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-04-22 |
| K954147 | MANAN MALECOT BASKET DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 |
| K954116 | SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP | Technical Products, Inc. | 1995-11-06 |
| K920423 | OLYMPIC SMART SCALE CARE CENTER | Olympic Medical Corp. | 1992-06-11 |
Legacy Summary#
summary
FDA Review#
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