The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Smartneedle(r) Over-the-needle Catheter.
| Device ID | K932777 |
| 510k Number | K932777 |
| Device Name: | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Manuel Javier |
| Correspondent | Manuel Javier PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1993-10-07 |