The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Universal Slittable Outer Catheter.
| Device ID | K130257 |
| 510k Number | K130257 |
| Device Name: | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Contact | Colleen Canan |
| Correspondent | Colleen Canan ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067004291 | K130257 | 000 |
| 05415067004185 | K130257 | 000 |
| 05415067004192 | K130257 | 000 |
| 05415067004208 | K130257 | 000 |
| 05415067004215 | K130257 | 000 |
| 05415067004222 | K130257 | 000 |
| 05415067004239 | K130257 | 000 |
| 05415067004246 | K130257 | 000 |
| 05415067004253 | K130257 | 000 |
| 05415067004260 | K130257 | 000 |
| 05415067004277 | K130257 | 000 |
| 05415067004284 | K130257 | 000 |
| 05415067004178 | K130257 | 000 |