Cleared Traditional

K843261 - ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD

K843261 is an FDA 510(k) clearance for ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD, manufactured by Angiosystems, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K843261 · Angiosystems, Inc. · Cardiovascular device
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Sep 1984
Decision
22d
Days
Class 2
Risk

K843261 is an FDA 510(k) clearance for the ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Angiosystems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Angiosystems, Inc. devices

FDA 510(k) Submission Details - K843261

510(k) Number K843261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date September 11, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 85
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K843261.
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URESIL CAROTID ARTERY SIZERS
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MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · Mallinckrodt Critical Care · Jul 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
CARDIAC CATHETERIZATION PACK
K840671 · Professional Medical Services · Mar 1984