The following data is part of a premarket notification filed by Upstream Peripheral Technologies with the FDA for Upstream Gr Catheter.
| Device ID | K120964 |
| 510k Number | K120964 |
| Device Name: | UPSTREAM GR CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | UPSTREAM PERIPHERAL TECHNOLOGIES 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan UPSTREAM PERIPHERAL TECHNOLOGIES 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204519106AA0 | K120964 | 000 |
| M2045191060 | K120964 | 000 |