Cleared Special

K003454 - A1-CS-SB Y-ADAPTER, MODEL 124 871

K003454 is an FDA 510(k) clearance for A1-CS-SB Y-ADAPTER, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Special 510(k) pathway after a 72-day FDA review.

K003454 · Biotronik, Inc. · Cardiovascular device
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Jan 2001
Decision
72d
Days
Class 2
Risk

K003454 is an FDA 510(k) clearance for the A1-CS-SB Y-ADAPTER, MODEL 124 871. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003454

510(k) Number K003454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 07, 2000
Decision Date January 18, 2001
Days to Decision 72 days
Submission Type Special
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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 102
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K003454.
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · Oscor, Inc. · Jun 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
K024156 · Oscor, Inc. · Jan 2003
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · Oscor, Inc. · May 2001
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular · Feb 2000
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · Medtronic Vascular · Oct 1998
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · Biotronik, Inc. · Aug 1997
K003454 · A1-CS-SB Y-ADAPTER, MODEL 124 871
Download PDF Biotronik, Inc.