The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Positive Placement Con/epidural An.
| Device ID | K801912 |
| 510k Number | K801912 |
| Device Name: | ARROW POSITIVE PLACEMENT CON/EPIDURAL AN |
| Classification | Anesthesia Conduction Kit |
| Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Correspondent | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-11 |
| Decision Date | 1980-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902009747 | K801912 | 000 |
| 30801902013768 | K801912 | 000 |
| 20801902162971 | K801912 | 000 |
| 20801902202165 | K801912 | 000 |
| 20801902202097 | K801912 | 000 |
| 20801902201953 | K801912 | 000 |
| 20801902202646 | K801912 | 000 |
| 20801902202653 | K801912 | 000 |
| 24026704736762 | K801912 | 000 |
| 20801902210177 | K801912 | 000 |
| 20801902195870 | K801912 | 000 |
| 30801902042447 | K801912 | 000 |
| 20801902005094 | K801912 | 000 |
| 20801902011934 | K801912 | 000 |
| 30801902126376 | K801912 | 000 |
| 20801902130963 | K801912 | 000 |
| 20801902139775 | K801912 | 000 |
| 20801902130727 | K801912 | 000 |
| 30801902130663 | K801912 | 000 |
| 40801902126373 | K801912 | 000 |
| 40801902126298 | K801912 | 000 |
| 40801902126090 | K801912 | 000 |
| 20801902114017 | K801912 | 000 |
| 20801902114260 | K801912 | 000 |
| 20801902200604 | K801912 | 000 |