The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Radiopaque 7 Frx 12-polyurethane Multi.
| Device ID | K840336 |
| 510k Number | K840336 |
| Device Name: | RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI |
| Classification | Catheter, Percutaneous |
| Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-25 |
| Decision Date | 1984-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902003318 | K840336 | 000 |