DELTA-FLOW
Catheter, Continuous Flush
TRI-DELTA INTL.
The following data is part of a premarket notification filed by Tri-delta Intl. with the FDA for Delta-flow.
Pre-market Notification Details
| Device ID | K780479 |
| 510k Number | K780479 |
| Device Name: | DELTA-FLOW |
| Classification | Catheter, Continuous Flush |
| Applicant | TRI-DELTA INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-27 |
| Decision Date | 1978-11-22 |
NIH GUDID Devices
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