Cleared Traditional

K961471 - INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)

K961471 is an FDA 510(k) clearance for INDEFLATOR 20/30 INFLATION DEVICE AND 2..., manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K961471 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
21d
Days
Class 2
Risk

K961471 is an FDA 510(k) clearance for the INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR ..... 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 May 8, 1996 after a review of 21 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

FDA 510(k) Submission Details - K961471

510(k) Number K961471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 17, 1996
Decision Date May 08, 1996
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K961471.
INTELLISYSTEM II COLOR MONITOR
K993341 · Merit Medical Systems, Inc. · Oct 1999
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K962495 · Advanced Cardiovascular Systems, Inc. · Sep 1996
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983 · Medtronics Interventional Vascular · May 1996
USCI IDEAL PTCA KIT
K953522 · Ryder Intl. Corp. · Apr 1996
BREEZE DIGITAL INFLATION DEVICE
K953676 · Namic · Mar 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996