The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Bipal Biopsy Forceps.
Device ID | K914567 |
510k Number | K914567 |
Device Name: | CORDIS BIPAL BIOPSY FORCEPS |
Classification | Device, Biopsy, Endomyocardial |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Tamara Harder |
Correspondent | Tamara Harder CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DWZ |
CFR Regulation Number | 870.4075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-15 |
Decision Date | 1991-12-18 |