Cleared Traditional

K904491 - TMP LEFT ATRIAL PRESSURE CATH CAT.# 100...

K904491 is an FDA 510(k) clearance for TMP LEFT ATRIAL PRESSURE CATH CAT.# 100..., manufactured by Lifestream Int'L, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K904491 · Lifestream Int'L, Inc. · Cardiovascular device
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Feb 1991
Decision
122d
Days
Class 2
Risk

K904491 is an FDA 510(k) clearance for the TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K904491

510(k) Number K904491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date February 01, 1991
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K904491.
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ACS ANGIOSCOPIC CATHETER
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SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · Scimed Life Systems, Inc. · Feb 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · C.R. Bard, Inc. · Feb 1991
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
K903199 · Medex, Inc. · Dec 1990