The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Adapter, Catheter Sheath.
| Device ID | K781846 |
| 510k Number | K781846 |
| Device Name: | ADAPTER, CATHETER SHEATH |
| Classification | Accessories, Catheter |
| Applicant | ARROW INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Correspondent | ARROW INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-01 |
| Decision Date | 1978-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40801902122849 | K781846 | 000 |
| 30801902013935 | K781846 | 000 |
| 20801902148111 | K781846 | 000 |
| 40801902121231 | K781846 | 000 |