Flowcardia Flowmater Injector, Model Inj 100

by Flowcardia, Inc. 510(k)

Active United States

510(k) K090621

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK090621	Date19 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Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number: K090621
FDA Product Code: DXT

Device Class: Class II
Regulation: 21 CFR Part 870.1650
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Other devices from Flowcardia, Inc.

The Crosser 14 Otw Catheter, Model CRU014

Class II
Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02

Class II
Microsheath Xl Catheters

Class II
Vp Wire GW140ST (.014 165cm, Standar), Model GW140ST; Vp Wire GW140SO (.014 165cm, Soft) Model GW140SO

Class II
The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200

Class II
Modification to the Crosser System

Class II

See all devices from Flowcardia, Inc. →