The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Cg+ Arrow Picc Powered By Arrow Vps Stylet.
| Device ID | K122545 |
| 510k Number | K122545 |
| Device Name: | CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Elizabeth Duncan |
| Correspondent | Elizabeth Duncan ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX 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 | 2012-08-21 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902087981 | K122545 | 000 |
| 20801902138501 | K122545 | 000 |
| 20801902167716 | K122545 | 000 |
| 20801902167693 | K122545 | 000 |
| 20801902167648 | K122545 | 000 |
| 20801902167631 | K122545 | 000 |
| 20801902167624 | K122545 | 000 |
| 40801902127127 | K122545 | 000 |
| 40801902127097 | K122545 | 000 |
| 40801902127066 | K122545 | 000 |
| 40801902124089 | K122545 | 000 |
| 40801902124041 | K122545 | 000 |
| 40801902123990 | K122545 | 000 |
| 20801902087984 | K122545 | 000 |
| 20801902078487 | K122545 | 000 |
| 20801902078470 | K122545 | 000 |
| 20801902211907 | K122545 | 000 |
| 20801902211891 | K122545 | 000 |
| 20801902138518 | K122545 | 000 |
| 20801902161790 | K122545 | 000 |
| 20801902161721 | K122545 | 000 |
| 30801902087974 | K122545 | 000 |
| 30801902087899 | K122545 | 000 |
| 30801902078484 | K122545 | 000 |
| 30801902078477 | K122545 | 000 |
| 30801902078460 | K122545 | 000 |
| 20801902127093 | K122545 | 000 |
| 20801902127062 | K122545 | 000 |
| 20801902123996 | K122545 | 000 |
| 30801902127120 | K122545 | 000 |
| 30801902124082 | K122545 | 000 |
| 30801902124044 | K122545 | 000 |
| 10801902087970 | K122545 | 000 |
| 10801902087895 | K122545 | 000 |
| 10801902078466 | K122545 | 000 |
| 20801902161387 | K122545 | 000 |
| 20801902161370 | K122545 | 000 |
| 20801902161738 | K122545 | 000 |
| 20801902208600 | K122545 | 000 |