The following data is part of a premarket notification filed by Perouse Medical with the FDA for Pps Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, Pps Pi Pressure Injectable Safety Huber.
| Device ID | K120261 |
| 510k Number | K120261 |
| Device Name: | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER |
| Classification | Set, Administration, Intravascular |
| Applicant | Perouse Medical Route Du Manoir Ivry-le-Temple France, FR 60173 |
| Contact | Isabelle Jeanty |
| Correspondent | Isabelle Jeanty Perouse Medical Route Du Manoir Ivry-le-Temple France, FR 60173 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13661234011510 | K120261 | 000 |
| 13661234011329 | K120261 | 000 |
| 13661234011312 | K120261 | 000 |
| 13661234011305 | K120261 | 000 |
| 13661234011299 | K120261 | 000 |
| 13661234011282 | K120261 | 000 |
| 13661234011275 | K120261 | 000 |
| 13661234011268 | K120261 | 000 |
| 13661234011251 | K120261 | 000 |
| 13661234011244 | K120261 | 000 |
| 13661234011237 | K120261 | 000 |
| 13661234011220 | K120261 | 000 |
| 13661234011213 | K120261 | 000 |
| 13661234011206 | K120261 | 000 |
| 13661234011190 | K120261 | 000 |
| 13661234011183 | K120261 | 000 |
| 13661234011176 | K120261 | 000 |
| 13661234011336 | K120261 | 000 |
| 13661234011343 | K120261 | 000 |
| 13661234011503 | K120261 | 000 |
| 13661234011497 | K120261 | 000 |
| 13661234011480 | K120261 | 000 |
| 13661234011473 | K120261 | 000 |
| 13661234011466 | K120261 | 000 |
| 13661234011459 | K120261 | 000 |
| 13661234011442 | K120261 | 000 |
| 13661234011435 | K120261 | 000 |
| 13661234011428 | K120261 | 000 |
| 13661234011411 | K120261 | 000 |
| 13661234011404 | K120261 | 000 |
| 13661234011398 | K120261 | 000 |
| 13661234011381 | K120261 | 000 |
| 13661234011374 | K120261 | 000 |
| 13661234011367 | K120261 | 000 |
| 13661234011350 | K120261 | 000 |
| 13661234011169 | K120261 | 000 |