The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Fischell Kink Resist Percut Sheath Intro Set.
| Device ID | K924607 |
| 510k Number | K924607 |
| Device Name: | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-11 |
| Decision Date | 1993-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902008542 | K924607 | 000 |
| 30801902001796 | K924607 | 000 |
| 20801902001782 | K924607 | 000 |
| 20801902001744 | K924607 | 000 |
| 30801902001703 | K924607 | 000 |
| 30801902001680 | K924607 | 000 |
| 20801902195740 | K924607 | 000 |
| 20801902195665 | K924607 | 000 |
| 20801902192510 | K924607 | 000 |
| 30801902192425 | K924607 | 000 |
| 20801902201038 | K924607 | 000 |
| 30801902200953 | K924607 | 000 |
| 30801902200755 | K924607 | 000 |
| 20801902200741 | K924607 | 000 |
| 30801902201028 | K924607 | 000 |
| 30801902001802 | K924607 | 000 |
| 30801902001864 | K924607 | 000 |
| 20801902001881 | K924607 | 000 |
| 20801902008538 | K924607 | 000 |
| 30801902008528 | K924607 | 000 |
| 20801902008354 | K924607 | 000 |
| 20801902008347 | K924607 | 000 |
| 30801902008320 | K924607 | 000 |
| 20801902002079 | K924607 | 000 |
| 30801902002045 | K924607 | 000 |
| 30801902002038 | K924607 | 000 |
| 20801902002017 | K924607 | 000 |
| 30801902001970 | K924607 | 000 |
| 30801902001963 | K924607 | 000 |
| 30801902001956 | K924607 | 000 |
| 30801902001925 | K924607 | 000 |
| 30801902001895 | K924607 | 000 |
| 30801902200960 | K924607 | 000 |