Cleared Traditional

K865013 - ASTRA T2, T4 AND T6

K865013 is an FDA 510(k) clearance for ASTRA T2, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K865013 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Feb 1987
Decision
58d
Days
Class 3
Risk

K865013 is an FDA 510(k) clearance for the ASTRA T2, T4 AND T6. 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 February 19, 1987 after a review of 58 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 Cardiac Pacemakers, Inc. devices

FDA 510(k) Submission Details - K865013

510(k) Number K865013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date February 19, 1987
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K865013.
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · Telectronics, Inc. · Aug 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · Medtronic Vascular · Aug 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · Telectronics, Inc. · Jun 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · Ela Medical, Inc. · Feb 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · Pacesetter Systems · Feb 1987
EDP-20 PACEMAKER
K860036 · Biotronik Sales, Inc. · Jan 1987