The following data is part of a premarket notification filed by Icu Medical Inc with the FDA for Punctur-guard Winged Set For Blood Collection, Model 5118.
| Device ID | K041410 |
| 510k Number | K041410 |
| Device Name: | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL INC 129 RESERVOIR RD. Vernon, CT 06066 -5705 |
| Contact | Dale Fairchild |
| Correspondent | Dale Fairchild ICU MEDICAL INC 129 RESERVOIR RD. Vernon, CT 06066 -5705 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-27 |
| Decision Date | 2004-07-28 |