510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251358Substantially Equivalent

Bridge Plus Occlusion Balloon (590-002)

Philips Image Guided Therapy Devices, Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251358 is the FDA 510(k) clearance record for Bridge Plus Occlusion Balloon (590-002), a class II device, cleared for Philips Image Guided Therapy Devices on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list one 510(k) clearance for Philips Image Guided Therapy Devices. As of , FDA records show no recalls naming K251358.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Image Guided Therapy Devices 9965 Federal Dr., Colorado Springs CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJN

Trailing 12 months

FDA records hold no clearances under product code MJN in the trailing twelve months.

FDA records show no clearances under product code MJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260