Cleared Traditional

K842394 - ASTRA 2

K842394 is the FDA 510(k) clearance for ASTRA 2 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K842394 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Oct 1984
Decision
120d
Days
Class 3
Risk

K842394 is an FDA 510(k) clearance for the ASTRA 2, ASTRA 3, 4 & 6. 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 October 17, 1984 after a review of 120 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 K842394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date October 17, 1984
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 272
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K842394.
PULSE GENERATOR 686, 686B 686L
K841230 · Siemens Elema AB · Dec 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · Siemens Elema AB · Dec 1984
IMPLANTABLE PROGRAMMABLE PULSE GENERAT
K842473 · Telectronics, Inc. · Oct 1984
MEDTRONIC 5984-5984LP-5985
K843837 · Medtronic Vascular · Oct 1984
MEDTRONIC 8437/8438
K843089 · Medtronic Vascular · Aug 1984
PULSE GENERATOR 678L
K841233 · Siemens Elema AB · Jul 1984