The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 4f Nylex Angiography Catheter/5f Nylex Angiography Catheter.
| Device ID | K971646 |
| 510k Number | K971646 |
| Device Name: | 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Elena Jugo |
| Correspondent | Elena Jugo CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-05 |
| Decision Date | 1997-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705032010771 | K971646 | 000 |
| 10705032010542 | K971646 | 000 |
| 10705032010559 | K971646 | 000 |
| 10705032010573 | K971646 | 000 |
| 10705032010580 | K971646 | 000 |
| 10705032010597 | K971646 | 000 |
| 10705032010610 | K971646 | 000 |
| 10705032010627 | K971646 | 000 |
| 10705032010641 | K971646 | 000 |
| 20705032010655 | K971646 | 000 |
| 10705032010665 | K971646 | 000 |
| 10705032010672 | K971646 | 000 |
| 10705032010689 | K971646 | 000 |
| 10705032010702 | K971646 | 000 |
| 10705032010719 | K971646 | 000 |
| 10705032010726 | K971646 | 000 |
| 10705032010733 | K971646 | 000 |
| 10705032010740 | K971646 | 000 |
| 10705032010535 | K971646 | 000 |