The following data is part of a premarket notification filed by Ivac Medical Systems with the FDA for Smartsite Access Pin.
| Device ID | K970485 |
| 510k Number | K970485 |
| Device Name: | SMARTSITE ACCESS PIN |
| Classification | Set, Administration, Intravascular |
| Applicant | IVAC MEDICAL SYSTEMS 10221 WATERIDGE CIRCLE San Diego, CA 92121 |
| Contact | Renee L Fluet |
| Correspondent | Renee L Fluet IVAC MEDICAL SYSTEMS 10221 WATERIDGE CIRCLE San Diego, CA 92121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403239579 | K970485 | 000 |
| 37613203011663 | K970485 | 000 |
| 37613203010420 | K970485 | 000 |
| 37613203011786 | K970485 | 000 |
| 37613203011809 | K970485 | 000 |
| 37613203011823 | K970485 | 000 |
| 50885403235021 | K970485 | 000 |