Cleared Traditional

K850271 - ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

K850271 is an FDA 510(k) clearance for ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAV..., manufactured by Angiomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K850271 · Angiomedics, Inc. · Cardiovascular device
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Apr 1985
Decision
70d
Days
Class 2
Risk

K850271 is an FDA 510(k) clearance for the ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Angiomedics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 3, 1985 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Angiomedics, Inc. devices

FDA 510(k) Submission Details - K850271

510(k) Number K850271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date April 03, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 421
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K850271.
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