The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Hands-off Thermo-pace.
| Device ID | K895268 |
| 510k Number | K895268 |
| Device Name: | ARROW HANDS-OFF THERMO-PACE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-23 |
| Decision Date | 1989-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902013973 | K895268 | 000 |
| 40801902121361 | K895268 | 000 |
| 20801902192299 | K895268 | 000 |
| 20801902192282 | K895268 | 000 |
| 20801902192275 | K895268 | 000 |
| 20801902192268 | K895268 | 000 |
| 20801902208563 | K895268 | 000 |
| 20801902192251 | K895268 | 000 |
| 20801902192244 | K895268 | 000 |
| 20801902208556 | K895268 | 000 |
| 20801902208549 | K895268 | 000 |
| 20801902208587 | K895268 | 000 |
| 20801902208594 | K895268 | 000 |
| 40801902121323 | K895268 | 000 |
| 40801902121347 | K895268 | 000 |
| 20801902180920 | K895268 | 000 |
| 30801902004025 | K895268 | 000 |
| 30801902003998 | K895268 | 000 |
| 30801902003974 | K895268 | 000 |
| 30801902003592 | K895268 | 000 |
| 30801902003585 | K895268 | 000 |
| 30801902003578 | K895268 | 000 |
| 30801902003561 | K895268 | 000 |
| 30801902003158 | K895268 | 000 |
| 30801902003097 | K895268 | 000 |
| 30801902128899 | K895268 | 000 |
| 30801902128882 | K895268 | 000 |
| 40801902121378 | K895268 | 000 |
| 20801902208570 | K895268 | 000 |