The following data is part of a premarket notification filed by Upstream Peripheral Technologies with the FDA for Upstream Needle Holder, Upstream Needle Holder With Shut-off Connector.
| Device ID | K112887 |
| 510k Number | K112887 |
| Device Name: | UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR |
| Classification | Introducer, Catheter |
| Applicant | UPSTREAM PERIPHERAL TECHNOLOGIES 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan UPSTREAM PERIPHERAL TECHNOLOGIES 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132020736 | K112887 | 000 |
| M204519001AA0 | K112887 | 000 |
| M2045190051 | K112887 | 000 |
| M2045190010 | K112887 | 000 |