Cleared Traditional

K960983 - MEDTRONIC EVERST 30 INFLATION DEVICE/SU...

K960983 is an FDA 510(k) clearance for MEDTRONIC EVERST 30 INFLATION DEVICE/SU..., manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K960983 · Medtronics Interventional Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
80d
Days
Class 2
Risk

K960983 is an FDA 510(k) clearance for the MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 80 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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K960983

510(k) Number K960983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date May 30, 1996
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 38
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K960983.
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · Vanguard Medical Concepts, Inc. · Jan 2002
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
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
K961471 · Advanced Cardiovascular Systems, Inc. · May 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
OSCILFLATOR
K952566 · Surgical Technologies, Inc. · Aug 1995