Cleared Traditional

K920601 - ASTRA T2, ASTRA T4, ASTRA T6

K920601 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 260-day FDA review.

K920601 · Cardiac Pacemakers, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
260d
Days
Class 3
Risk

K920601 is an FDA 510(k) clearance for the ASTRA T2, ASTRA T4, ASTRA 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 October 28, 1992 after a review of 260 days - an extended review 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 - K920601

510(k) Number K920601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date October 28, 1992
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 125d · This submission: 260d
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 K920601.
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
K923026 · Biotronik, GmbH & Co. · Aug 1993
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868 · Cardiac Control Systems, Inc. · May 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · Medtronic Vascular · May 1993
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
K920530 · Intermedics, Inc. · Mar 1992
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157 · Schneider Intl., Ltd. · Mar 1992
PIKOS 01 & PIKOS E 01
K914109 · Biotronik, GmbH & Co. · Feb 1992