510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940385Substantially Equivalent

Navigator-Mp Catheter Location Instrument

Navion Biomedical Corp., Stoughton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940385 is the FDA 510(k) clearance record for NAVIGATOR-MP CATHETER LOCATION INSTRUMENT, a class II device, cleared for Navion Biomedical Corp. on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 5 510(k) clearances for Navion Biomedical Corp., from to . As of , FDA records show no recalls naming K940385.

Clearance record

Decision date
Received
(127 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Navion Biomedical Corp. 312 Tosca Dr., Stoughton MA
510(k) summary
Summary
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260