Cleared Traditional

INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) (K962495) - FDA 510(k) Clearance

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

K962495 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Sep 1996
Decision
78d
Days
Class 2
Risk

K962495 is an FDA 510(k) clearance for the INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTA.... Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 78 days - a notably fast clearance cycle.

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: 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K962495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date September 12, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
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.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 56
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K962495.
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · Medtronic Vascular · Apr 2022
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
basixTOUCH40 Inflation Syringe
K153672 · Merit Medical Systems, Inc. · Jan 2016
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
BASIXTOUCH
K130566 · Merit Medical Systems, Inc. · Jun 2013