The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Peripherally Inserted Medline Catheter.
| Device ID | K963257 |
| 510k Number | K963257 |
| Device Name: | PERIPHERALLY INSERTED MEDLINE CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1997-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902094873 | K963257 | 000 |
| 20801902142218 | K963257 | 000 |
| 20801902012122 | K963257 | 000 |
| 10801902011982 | K963257 | 000 |
| 10801902044942 | K963257 | 000 |
| 30801902123344 | K963257 | 000 |
| 30801902123351 | K963257 | 000 |
| 20801902123330 | K963257 | 000 |
| 50801902094839 | K963257 | 000 |
| 20801902139379 | K963257 | 000 |
| 20801902094869 | K963257 | 000 |
| 20801902205425 | K963257 | 000 |
| 20801902205432 | K963257 | 000 |
| 20801902205449 | K963257 | 000 |
| 20801902111672 | K963257 | 000 |
| 40801902123211 | K963257 | 000 |
| 20801902164012 | K963257 | 000 |
| 20801902094845 | K963257 | 000 |
| 20801902094852 | K963257 | 000 |
| 50801902094877 | K963257 | 000 |
| 40801902011983 | K963257 | 000 |
| 30801902044960 | K963257 | 000 |
| 30801902063572 | K963257 | 000 |
| 30801902084454 | K963257 | 000 |
| 30801902092503 | K963257 | 000 |
| 30801902094835 | K963257 | 000 |
| 30801902094842 | K963257 | 000 |
| 30801902094859 | K963257 | 000 |
| 30801902094866 | K963257 | 000 |
| 30801902044953 | K963257 | 000 |
| 30801902044946 | K963257 | 000 |
| 40801902012133 | K963257 | 000 |
| 50801902123348 | K963257 | 000 |
| 50801902123355 | K963257 | 000 |
| 30801902011986 | K963257 | 000 |
| 30801902011993 | K963257 | 000 |
| 30801902012006 | K963257 | 000 |
| 30801902012129 | K963257 | 000 |
| 30801902012136 | K963257 | 000 |
| 00801902201478 | K963257 | 000 |