Cleared Traditional

K860585 - ASTRA T2

K860585 is the FDA 510(k) clearance for ASTRA T2 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K860585 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jul 1986
Decision
148d
Days
Class 3
Risk

K860585 is an FDA 510(k) clearance for the ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 16, 1986 after a review of 148 days - within the typical 510(k) review window.

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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K860585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1986
Decision Date July 16, 1986
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 273
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K860585.
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · Intermedics, Inc. · Sep 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 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/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · Medtronic Vascular · Jun 1986