Cleared Traditional

K890785 - ASTRA T2

K890785 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 23-day FDA review.

K890785 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Mar 1989
Decision
23d
Days
Class 3
Risk

K890785 is an FDA 510(k) clearance for the ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE. 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 March 10, 1989 after a review of 23 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

Submission Details

510(k) Number K890785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1989
Decision Date March 10, 1989
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 K890785.
OPTIMA MPT AND SPT PACEMAKERS
K891231 · Telectronics, Inc. · Sep 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · Medtronic Vascular · Aug 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267 · Pacesetter Systems · Mar 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · Pacesetter Systems · Feb 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411 · Telectronics, Inc. · Jan 1989
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · Medtronic Vascular · Nov 1988