Datascope's 8FR. 50cc Intra-Aortic Balloon Catheter and Accessories, Models 0684, 00-0498-01, 02

by Datascope Corp., Cardiac Assist Division 510(k)

Active United States

510(k) K091449

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK091449	Date18 Jun 2009Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number: K091449
FDA Product Code: DSP
Models / Variants: 0684
00-0498-01
02

Device Class: Class II
Regulation: 21 CFR Part 870.3535
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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