The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Transit/rapidtransit/speedster/prowler Infusion Catheter.
Device ID | K972518 |
510k Number | K972518 |
Device Name: | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER |
Classification | Catheter, Continuous Flush |
Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Lisa Wells |
Correspondent | Lisa Wells CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-07 |
Decision Date | 1997-11-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886704028369 | K972518 | 000 |
10886704028352 | K972518 | 000 |
10886704028345 | K972518 | 000 |
10886704028314 | K972518 | 000 |
10886704028253 | K972518 | 000 |
10886704028246 | K972518 | 000 |
10886704028338 | K972518 | 000 |
10886704028321 | K972518 | 000 |