The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Powerflex Pro Percutaneous Transluminal Angioplasty Catheter.
| Device ID | K121442 |
| 510k Number | K121442 |
| Device Name: | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS CORPORATION 430 RT. 22 EAST Bridgewater, NJ 08807 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall CORDIS CORPORATION 430 RT. 22 EAST Bridgewater, NJ 08807 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2012-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032060124 | K121442 | 000 |
| 20705032059722 | K121442 | 000 |
| 20705032059739 | K121442 | 000 |
| 20705032059746 | K121442 | 000 |
| 20705032059753 | K121442 | 000 |
| 20705032059760 | K121442 | 000 |
| 20705032059876 | K121442 | 000 |
| 20705032059883 | K121442 | 000 |
| 20705032059999 | K121442 | 000 |
| 20705032060001 | K121442 | 000 |
| 20705032060117 | K121442 | 000 |
| 20705032059715 | K121442 | 000 |