The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow M.i.s. Multi-lumen Catheteriza.
| Device ID | K820648 |
| 510k Number | K820648 |
| Device Name: | ARROW M.I.S. MULTI-LUMEN CATHETERIZA |
| Classification | Catheter, Percutaneous |
| Applicant | ARROW INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-09 |
| Decision Date | 1982-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902099366 | K820648 | 000 |
| 20801902196655 | K820648 | 000 |
| 20801902196648 | K820648 | 000 |
| 20801902208471 | K820648 | 000 |
| 20801902208457 | K820648 | 000 |
| 20801902201052 | K820648 | 000 |
| 20801902201045 | K820648 | 000 |