The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Piggy Lock Needle Housing.
| Device ID | K910546 |
| 510k Number | K910546 |
| Device Name: | PIGGY LOCK NEEDLE HOUSING |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Araceli C Fancher |
| Correspondent | Araceli C Fancher ICU MEDICAL, INC. 142 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709041575 | K910546 | 000 |
| 10887709031453 | K910546 | 000 |
| 10887709018522 | K910546 | 000 |