Cleared Traditional

K090621 - FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100

K090621 is an FDA 510(k) clearance for FLOWCARDIA FLOWMATER INJECTOR, manufactured by Flowcardia, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K090621 · Flowcardia, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
102d
Days
Class 2
Risk

K090621 is an FDA 510(k) clearance for the FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Flowcardia, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 19, 2009 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090621

510(k) Number K090621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date June 19, 2009
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 197
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K090621.
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
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REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
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DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
K090487 · Coeur, Inc. · Oct 2009
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
K082439 · Shandong Weigao Medical Polymer Co., Ltd. · Mar 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
SYRINGE WITH HANDI-FIL
K082212 · Mallinckrodt Inc., Liebel-Flarsheim Business · Jan 2009
K090621 · FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
Download PDF FDA Summary Flowcardia, Inc.