The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (picc) Model: S-44041-002, S-45041-002, S-45504.
| Device ID | K100635 |
| 510k Number | K100635 |
| Device Name: | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Tracy Maddock |
| Correspondent | Tracy Maddock ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-03-05 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902111549 | K100635 | 000 |
| 30801902100406 | K100635 | 000 |
| 30801902092763 | K100635 | 000 |
| 20801902125495 | K100635 | 000 |
| 20801902125488 | K100635 | 000 |
| 40801902124225 | K100635 | 000 |
| 20801902113256 | K100635 | 000 |
| 40801902124256 | K100635 | 000 |
| 20801902113249 | K100635 | 000 |