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

Catheter, Pressure Monitoring, Cardiac

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

OBI is the FDA product code for Catheter, Pressure Monitoring, Cardiac, a class II device type, regulated under 21 CFR 870.1200. FDA's definition for this code reads: "To measure pressure within the cardiovascular system". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OBI
Device name
Catheter, Pressure Monitoring, Cardiac
FDA definition
To measure pressure within the cardiovascular system.
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
1
Ingested recalls
1

Clearances, product code OBI

By decision year
1 clearance under product code OBI with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBI by decision year
YearClearances
20191

Applicants with the most clearances

Product code OBI
Applicants holding the most 510(k) clearances under product code OBI
ApplicantClearances
Acist Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code