The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Peritoneal Lavage Catherization K.
| Device ID | K811627 |
| 510k Number | K811627 |
| Device Name: | ARROW PERITONEAL LAVAGE CATHERIZATION K |
| Classification | Catheter, Peritoneal |
| Applicant | ARROW INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-09 |
| Decision Date | 1981-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902111433 | K811627 | 000 |
| 30801902005244 | K811627 | 000 |
| 30801902005237 | K811627 | 000 |
| 20801902121725 | K811627 | 000 |
| 20801902162926 | K811627 | 000 |
| 00801902005243 | K811627 | 000 |
| 20801902197942 | K811627 | 000 |