Cleared Traditional

K871129 - CAVROPUMP

K871129 is the FDA 510(k) clearance for CAVROPUMP by Life-Tech Intl., Inc.. It is a Class 2 Gastroenterology & Urology device (product code DXT) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K871129 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Aug 1987
Decision
161d
Days
Class 2
Risk

K871129 is an FDA 510(k) clearance for the CAVROPUMP. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on August 28, 1987 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1650 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K871129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1987
Decision Date August 28, 1987
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K871129.
MEDRAD MRI INJECTION SYSTEM
K873173 · Medrad, Inc. · Feb 1988
NAMIC ANGIOGRAPHIC SYRINGE
K873955 · North American Instrument Corp. · Feb 1988
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · Advanced Cardiovascular Systems, Inc. · Oct 1987
CHIN-FOGARTY INFLATION DEVICE
K863596 · American Edwards Laboratories · Nov 1986
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537 · Cordis Corp. · Oct 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · C.R. Bard, Inc. · Sep 1986