Cleared Traditional

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) (K853136) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853136 · E.A. Fischione Instrument Mfg. · Cardiovascular device
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Dec 1985
Decision
130d
Days
Class 2
Risk

K853136 is an FDA 510(k) clearance for the MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER). Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by E.A. Fischione Instrument Mfg. (Pittsburgh, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 E.A. Fischione Instrument Mfg. devices

Submission Details

510(k) Number K853136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1985
Decision Date December 03, 1985
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
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 Cardiovascular devices follow this clearance model.