The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Prowler Infusion Catheters With Pre-shaped Tips.
Device ID | K003925 |
510k Number | K003925 |
Device Name: | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS |
Classification | Catheter, Continuous Flush |
Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
Contact | Amarilys Machado |
Correspondent | Amarilys Machado 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 | 2000-12-20 |
Decision Date | 2001-01-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886704028765 | K003925 | 000 |
10886704028628 | K003925 | 000 |
10886704028611 | K003925 | 000 |
10886704028604 | K003925 | 000 |
10886704028598 | K003925 | 000 |
10886704028581 | K003925 | 000 |
10886704028574 | K003925 | 000 |
10886704028550 | K003925 | 000 |
10886704028543 | K003925 | 000 |
10886704028536 | K003925 | 000 |
10886704028529 | K003925 | 000 |
10886704028635 | K003925 | 000 |
10886704028642 | K003925 | 000 |
10886704028659 | K003925 | 000 |
10886704028758 | K003925 | 000 |
10886704028741 | K003925 | 000 |
10886704028734 | K003925 | 000 |
10886704028727 | K003925 | 000 |
10886704028710 | K003925 | 000 |
10886704028703 | K003925 | 000 |
10886704028697 | K003925 | 000 |
10886704028680 | K003925 | 000 |
10886704028673 | K003925 | 000 |
10886704028666 | K003925 | 000 |
10886704028512 | K003925 | 000 |