The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Introducer Guide.
| Device ID | K001136 |
| 510k Number | K001136 |
| Device Name: | CORDIS INTRODUCER GUIDE |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Ariel Mactavish |
| Correspondent | Ariel Mactavish 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 | 2000-04-10 |
| Decision Date | 2000-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032064016 | K001136 | 000 |
| 20705032000977 | K001136 | 000 |
| 20705032000960 | K001136 | 000 |
| 20705032000953 | K001136 | 000 |
| 20705032000946 | K001136 | 000 |
| 20705032000939 | K001136 | 000 |
| 20705032000922 | K001136 | 000 |
| 20705032000908 | K001136 | 000 |
| 20705032000892 | K001136 | 000 |
| 20705032000885 | K001136 | 000 |
| 20705032000878 | K001136 | 000 |
| 20705032000984 | K001136 | 000 |
| 20705032000991 | K001136 | 000 |
| 20705032001004 | K001136 | 000 |
| 20705032064009 | K001136 | 000 |
| 20705032047484 | K001136 | 000 |
| 20705032047477 | K001136 | 000 |
| 20705032047460 | K001136 | 000 |
| 20705032047453 | K001136 | 000 |
| 20705032047408 | K001136 | 000 |
| 20705032047071 | K001136 | 000 |
| 20705032047033 | K001136 | 000 |
| 20705032001035 | K001136 | 000 |
| 20705032001028 | K001136 | 000 |
| 20705032000861 | K001136 | 000 |