Cleared Traditional

K901733 - MODIFIED FLOCATH PULMONARY ARTERY CATHETER

K901733 is an FDA 510(k) clearance for MODIFIED FLOCATH PULMONARY ARTERY CATHETER, manufactured by Cardio Metrics, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901733 · Cardio Metrics, Inc. · Cardiovascular device
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Jul 1990
Decision
90d
Days
Class 2
Risk

K901733 is an FDA 510(k) clearance for the MODIFIED FLOCATH PULMONARY ARTERY CATHETER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Cardio Metrics, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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.

View all Cardio Metrics, Inc. devices

FDA 510(k) Submission Details - K901733

510(k) Number K901733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date July 16, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 36
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K901733.
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
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NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631 · Nihon Kohden America, Inc. · Jan 1990
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K872068 · Advanced Technology Laboratories, Inc. · Sep 1987