The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Wester Star Catheter.
| Device ID | K954390 |
| 510k Number | K954390 |
| Device Name: | CORDIS WESTER STAR CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Mary Adams |
| Correspondent | Mary Adams CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835002058 | K954390 | 000 |
| 10846835002041 | K954390 | 000 |
| 10846835002034 | K954390 | 000 |
| 10846835002027 | K954390 | 000 |