Cleared Traditional

K862037 - MODIFY LABEL/PASYS & MOD 8316/17/18 IMP...

K862037 is the FDA 510(k) clearance for MODIFY LABEL/PASYS & MOD 8316/17/18 IMP... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K862037 · Medtronic Vascular · Cardiovascular device
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Jun 1986
Decision
20d
Days
Class 3
Risk

K862037 is an FDA 510(k) clearance for the MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Medtronic Vascular devices

Submission Details

510(k) Number K862037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date June 17, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K862037.
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · Cardiac Pacemakers, Inc. · Jul 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719 · Medtronic Vascular · Jul 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422 · Pacesetter Systems · Jun 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · Medtronic Vascular · Jun 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · Medtronic Vascular · Jun 1986
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
K860573 · Telectronics, Inc. · May 1986