Product code MAB— Cardiovascular

C.A.B. RING

Classification name: Marker, Cardiopulmonary Bypass (Vein Marker)
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Total cleared: 3
First cleared: 1989-08-17
Most recent: 2006-01-17

Market context for product code MAB

FDA has cleared 3 devices under product code MAB between 1989 and 2006, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20061 clearance
20011 clearance
19891 clearance

Top applicants under product code MAB

T. Korossurgical Instruments Corp.1 clearance
Medi-Sharp, Inc.1 clearance
First Call, Inc.1 clearance

Recent clearances under product code MAB

K052642 — SUTURING WASHERFirst Call, Inc.·2006-01-17
K001915 — GRAFT MARKER RINGT. Korossurgical Instruments Corp.·2001-04-27
K894268 — C.A.B. RINGMedi-Sharp, Inc.·1989-08-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.