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

Reprocessed Intravascular Ultrasound Catheter

21 CFR 870.1200 / Cardiovascular
FDA source (opens on fda.gov)

OWQ is the FDA product code for Reprocessed Intravascular Ultrasound Catheter, a class II device type, regulated under 21 CFR 870.1200. FDA's definition for this code reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
OWQ
Device name
Reprocessed Intravascular Ultrasound Catheter
FDA definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
10

Clearances, product code OWQ

By decision year
31 clearances under product code OWQ with a decision year between 2002 and 2026, 2023 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code OWQ by decision year
YearClearances
20021
20052
20071
20091
20111
20121
20162
20172
20181
20193
20201
20222
20238
20241
20253
20261

Applicants with the most clearances

Product code OWQ
Applicants holding the most 510(k) clearances under product code OWQ
ApplicantClearances
Innovative Health, LLC.7
Sterilmed Inc6
Stryker Sustainability Solutions5
Abbott Medical3
Medline ReNewal3
Vein 360, LLC3
Northeast Scientific Inc.2
Alliance Medical Corp.1
Surgical Instrument Services and Savings, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order