The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hemodraw Arterial Blood Sampling System.
| Device ID | K071269 |
| 510k Number | K071269 |
| Device Name: | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM |
| Classification | Arterial Blood Sampling Kit |
| Applicant | SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Barbara Law |
| Correspondent | Barbara Law SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688503730 | K071269 | 000 |
| 50351688501958 | K071269 | 000 |
| 50351688501965 | K071269 | 000 |
| 50351688501972 | K071269 | 000 |
| 50351688502269 | K071269 | 000 |
| 50351688502276 | K071269 | 000 |
| 50351688502283 | K071269 | 000 |
| 50351688502702 | K071269 | 000 |
| 50351688502733 | K071269 | 000 |
| 50351688503204 | K071269 | 000 |
| 50351688503211 | K071269 | 000 |
| 50351688503389 | K071269 | 000 |
| 50351688503396 | K071269 | 000 |
| 50351688503402 | K071269 | 000 |
| 50351688503624 | K071269 | 000 |
| 50351688503686 | K071269 | 000 |
| 50351688501941 | K071269 | 000 |