The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Prowler Select (10, 14, And Plus) Infusion Catheters With And Without Pre-shaped Tips.
Device ID | K021591 |
510k Number | K021591 |
Device Name: | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS |
Classification | Catheter, Continuous Flush |
Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
Contact | Maritza Celaya |
Correspondent | Maritza Celaya CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-15 |
Decision Date | 2002-05-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886704028895 | K021591 | 000 |
10886704028789 | K021591 | 000 |
10886704028796 | K021591 | 000 |
10886704028802 | K021591 | 000 |
10886704028819 | K021591 | 000 |
10886704028826 | K021591 | 000 |
10886704028840 | K021591 | 000 |
10886704028857 | K021591 | 000 |
10886704028864 | K021591 | 000 |
10886704028871 | K021591 | 000 |
10886704028888 | K021591 | 000 |
10886704028772 | K021591 | 000 |