The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Cg+ Arrow Picc Powered By Arrow Vps Stylet.
| Device ID | K130876 |
| 510k Number | K130876 |
| Device Name: | CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Elizabeth Duncan |
| Correspondent | Elizabeth Duncan ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902091056 | K130876 | 000 |
| 40801902127103 | K130876 | 000 |
| 40801902127080 | K130876 | 000 |
| 40801902127073 | K130876 | 000 |
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| 30801902082559 | K130876 | 000 |
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| 30801902120763 | K130876 | 000 |
| 30801902120732 | K130876 | 000 |
| 30801902120718 | K130876 | 000 |
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| 20801902156642 | K130876 | 000 |
| 20801902156581 | K130876 | 000 |
| 10801902198089 | K130876 | 000 |