DURACATH
Catheter, Subclavian
IMPRA, INC.
The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Duracath.
Pre-market Notification Details
| Device ID | K901133 |
| 510k Number | K901133 |
| Device Name: | DURACATH |
| Classification | Catheter, Subclavian |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Bill Colone |
| Correspondent | Bill Colone IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-06-08 |
Trademark Results [DURACATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURACATH 75759364 2582861 Dead/Cancelled |
Advanced Neuromodulation Systems, Inc. 1999-07-23 |
 DURACATH 73424939 1281433 Dead/Cancelled |
DNA Medical, Inc. 1983-05-09 |
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