The following data is part of a premarket notification filed by Cordis Europa, N.v. with the FDA for Cordis Aviator Plus Pta Balloon Dilatation Catheter.
| Device ID | K071189 |
| 510k Number | K071189 |
| Device Name: | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, NL Nl-9301 Lj |
| Contact | Harm Hovinga |
| Correspondent | Harm Hovinga CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, NL Nl-9301 Lj |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032005965 | K071189 | 000 |
| 20705032005835 | K071189 | 000 |
| 20705032005828 | K071189 | 000 |
| 20705032005811 | K071189 | 000 |
| 20705032005804 | K071189 | 000 |
| 20705032005798 | K071189 | 000 |
| 20705032005781 | K071189 | 000 |
| 20705032005774 | K071189 | 000 |
| 20705032005767 | K071189 | 000 |
| 20705032005750 | K071189 | 000 |
| 20705032005743 | K071189 | 000 |
| 20705032005842 | K071189 | 000 |
| 20705032005859 | K071189 | 000 |
| 20705032005958 | K071189 | 000 |
| 20705032005941 | K071189 | 000 |
| 20705032005934 | K071189 | 000 |
| 20705032005927 | K071189 | 000 |
| 20705032005910 | K071189 | 000 |
| 20705032005903 | K071189 | 000 |
| 20705032005897 | K071189 | 000 |
| 20705032005880 | K071189 | 000 |
| 20705032005873 | K071189 | 000 |
| 20705032005866 | K071189 | 000 |
| 20705032005736 | K071189 | 000 |