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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