The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Slalom Pta Balloon Catheter.
| Device ID | K003159 |
| 510k Number | K003159 |
| Device Name: | CORDIS SLALOM PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Chuck Ryan |
| Correspondent | Chuck Ryan CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032061596 | K003159 | 000 |
| 20705032007150 | K003159 | 000 |
| 20705032007143 | K003159 | 000 |
| 20705032007129 | K003159 | 000 |
| 20705032007112 | K003159 | 000 |
| 20705032007068 | K003159 | 000 |
| 20705032007044 | K003159 | 000 |
| 20705032007037 | K003159 | 000 |
| 20705032007020 | K003159 | 000 |
| 20705032007013 | K003159 | 000 |
| 20705032007006 | K003159 | 000 |
| 20705032006993 | K003159 | 000 |
| 20705032006948 | K003159 | 000 |
| 20705032006924 | K003159 | 000 |
| 20705032006917 | K003159 | 000 |
| 20705032006900 | K003159 | 000 |
| 20705032006894 | K003159 | 000 |
| 20705032006887 | K003159 | 000 |
| 20705032007167 | K003159 | 000 |
| 20705032007181 | K003159 | 000 |
| 20705032007273 | K003159 | 000 |
| 20705032007600 | K003159 | 000 |
| 20705032007587 | K003159 | 000 |
| 20705032007570 | K003159 | 000 |
| 20705032007563 | K003159 | 000 |
| 20705032007549 | K003159 | 000 |
| 20705032007532 | K003159 | 000 |
| 20705032007488 | K003159 | 000 |
| 20705032007464 | K003159 | 000 |
| 20705032007457 | K003159 | 000 |
| 20705032007440 | K003159 | 000 |
| 20705032007426 | K003159 | 000 |
| 20705032007419 | K003159 | 000 |
| 20705032007365 | K003159 | 000 |
| 20705032007334 | K003159 | 000 |
| 20705032007327 | K003159 | 000 |
| 20705032007310 | K003159 | 000 |
| 20705032007280 | K003159 | 000 |
| 20705032006870 | K003159 | 000 |