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

Catheter, Ultrasound, Intravascular

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

OBJ is the FDA product code for Catheter, Ultrasound, Intravascular, 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 79 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
OBJ
Device name
Catheter, Ultrasound, Intravascular
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
80
Ingested recalls
23

Clearances, product code OBJ

By decision year
80 clearances under product code OBJ with a decision year between 2003 and 2026, 2025 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OBJ by decision year
YearClearances
20032
20044
20053
20073
20086
20093
20101
20114
20123
20134
20143
20154
20164
20176
20182
20191
20204
20213
20223
20233
20243
20257
20264

Applicants with the most clearances

Product code OBJ
Applicants holding the most 510(k) clearances under product code OBJ
ApplicantClearances
Volcano Corporation14
Boston Scientific Corporation13
Siemens Medical Solutions USA, Inc.11
Biosense Webster Inc9
Teleflex Medical5
Acist Medical Systems, Inc.3
Philips Image Guided Therapy Corporation3
Abbott Medical2
Conavi Medical Inc2
Luma Vision Limited2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 77 companies shown, in name order