The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cinch Qr Sgw Extension.
Device ID | K963171 |
510k Number | K963171 |
Device Name: | CINCH QR SGW EXTENSION |
Classification | Wire, Guide, Catheter |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Lisa Wells |
Correspondent | Lisa Wells CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-14 |
Decision Date | 1996-11-07 |
Summary: | summary |