The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Saf-t Closed Blood Collection System With Saf-holder Device, With 21g, 23g, 25g Saf-t Wing.
| Device ID | K081229 |
| 510k Number | K081229 |
| Device Name: | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brian Farias |
| Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-30 |
| Decision Date | 2008-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517081224 | K081229 | 000 |
| 35019517080937 | K081229 | 000 |
| 55019517080894 | K081229 | 000 |
| 35019517080883 | K081229 | 000 |
| 55019517080856 | K081229 | 000 |
| 55019517079027 | K081229 | 000 |
| 55019517050156 | K081229 | 000 |
| 35019517050145 | K081229 | 000 |
| 35019517050114 | K081229 | 000 |
| 35019517050107 | K081229 | 000 |
| 35019517050091 | K081229 | 000 |
| 55019517080948 | K081229 | 000 |
| 35019517080982 | K081229 | 000 |
| 35019517081194 | K081229 | 000 |
| 55019517081174 | K081229 | 000 |
| 35019517081156 | K081229 | 000 |
| 35019517081132 | K081229 | 000 |
| 55019517081112 | K081229 | 000 |
| 35019517081095 | K081229 | 000 |
| 35019517081088 | K081229 | 000 |
| 55019517081051 | K081229 | 000 |
| 55019517081044 | K081229 | 000 |
| 35019517080999 | K081229 | 000 |
| 35019517050060 | K081229 | 000 |