The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex, with the FDA for Cg+ Arrow Jacc.
| Device ID | K161765 |
| 510k Number | K161765 |
| Device Name: | CG+ Arrow JACC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Julie Lawson |
| Correspondent | Julie Lawson ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, 2400 BERNVILLE ROAD 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 | 2016-06-27 |
| Decision Date | 2016-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801902129311 | K161765 | 000 |
| 20801902188650 | K161765 | 000 |
| 20801902188643 | K161765 | 000 |
| 20801902188391 | K161765 | 000 |
| 20801902188384 | K161765 | 000 |
| 20801902129349 | K161765 | 000 |
| 20801902129332 | K161765 | 000 |
| 20801902129325 | K161765 | 000 |
| 20801902129295 | K161765 | 000 |