The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078.
| Device ID | K991531 |
| 510k Number | K991531 |
| Device Name: | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 |
| 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 | 1999-05-03 |
| Decision Date | 1999-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835004205 | K991531 | 000 |
| 10846835004151 | K991531 | 000 |
| 10846835004090 | K991531 | 000 |
| 10846835004069 | K991531 | 000 |
| 10846835004038 | K991531 | 000 |
| 10846835000801 | K991531 | 000 |
| 10846835000702 | K991531 | 000 |