The following data is part of a premarket notification filed by Concord/portex with the FDA for Accu-vent(tm) With Needle-pro(tm).
| Device ID | K912043 |
| 510k Number | K912043 |
| Device Name: | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) |
| Classification | Arterial Blood Sampling Kit |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-08 |
| Decision Date | 1991-07-05 |