The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Envoy And Vista Brite Tip.
Device ID | K000715 |
510k Number | K000715 |
Device Name: | ENVOY AND VISTA BRITE TIP |
Classification | Catheter, Percutaneous |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Dennis S Griffin |
Correspondent | Dennis S Griffin CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-02 |
Decision Date | 2000-03-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20705032065112 | K000715 | 000 |
20705032064214 | K000715 | 000 |
20705032064191 | K000715 | 000 |
20705032064177 | K000715 | 000 |
20705032064160 | K000715 | 000 |
20705032072721 | K000715 | 000 |
20705032067826 | K000715 | 000 |
20705032067451 | K000715 | 000 |
20705032065129 | K000715 | 000 |
20705032043004 | K000715 | 000 |
20705032042861 | K000715 | 000 |
20705032042922 | K000715 | 000 |
20705032064313 | K000715 | 000 |
20705032064252 | K000715 | 000 |
20705032064245 | K000715 | 000 |
20705032064238 | K000715 | 000 |
20705032064221 | K000715 | 000 |
20705032064184 | K000715 | 000 |
20705032064153 | K000715 | 000 |
20705032064146 | K000715 | 000 |
20705032064139 | K000715 | 000 |
20705032042083 | K000715 | 000 |