The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Picc-peripherally Inserted Central Catheter.
| Device ID | K930129 |
| 510k Number | K930129 |
| Device Name: | ARROW PICC-PERIPHERALLY INSERTED CENTRAL 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 - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1994-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902095290 | K930129 | 000 |
| 30801902012877 | K930129 | 000 |
| 30801902012860 | K930129 | 000 |
| 30801902012853 | K930129 | 000 |
| 30801902012839 | K930129 | 000 |
| 20801902012825 | K930129 | 000 |
| 30801902012679 | K930129 | 000 |
| 30801902012662 | K930129 | 000 |
| 30801902012488 | K930129 | 000 |
| 50801902123423 | K930129 | 000 |
| 30801902123429 | K930129 | 000 |
| 10801902094893 | K930129 | 000 |
| 20801902012481 | K930129 | 000 |
| 20801902058250 | K930129 | 000 |
| 20801902012665 | K930129 | 000 |
| 20801902095071 | K930129 | 000 |
| 20801902095101 | K930129 | 000 |
| 40801902123426 | K930129 | 000 |
| 20801902012894 | K930129 | 000 |
| 30801902012907 | K930129 | 000 |
| 20801902095286 | K930129 | 000 |
| 20801902095279 | K930129 | 000 |
| 30801902095269 | K930129 | 000 |
| 20801902095255 | K930129 | 000 |
| 20801902095248 | K930129 | 000 |
| 20801902095231 | K930129 | 000 |
| 30801902095092 | K930129 | 000 |
| 30801902095085 | K930129 | 000 |
| 30801902095078 | K930129 | 000 |
| 30801902094972 | K930129 | 000 |
| 30801902094897 | K930129 | 000 |
| 30801902094231 | K930129 | 000 |
| 30801902063541 | K930129 | 000 |
| 30801902058257 | K930129 | 000 |
| 30801902057441 | K930129 | 000 |
| 30801902052231 | K930129 | 000 |
| 30801902033902 | K930129 | 000 |
| 20801902052234 | K930129 | 000 |