Cleared Traditional

K800353 - ADAPTER KIT

K800353 is an FDA 510(k) clearance for ADAPTER KIT, manufactured by Daig Corp.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K800353 · Daig Corp. · Cardiovascular device
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May 1980
Decision
103d
Days
Class 2
Risk

K800353 is an FDA 510(k) clearance for the ADAPTER KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Daig Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Daig Corp. devices

FDA 510(k) Submission Details - K800353

510(k) Number K800353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1980
Decision Date May 28, 1980
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K800353.
ADAPTAID HELICAL COIL ADAPTER 365-14
K801039 · Intermedics, Inc. · Jul 1980
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · Intermedics, Inc. · Jul 1980
GE LEAD ADAPTER, MODEL 345-01
K801040 · Intermedics, Inc. · Jun 1980
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · Pacesetter Systems · Aug 1979
IMPLANTABLE HEART LEAD TERMINAL ADAPTER
K790436 · Arco Medical Products Co. · May 1979
IMPLANTABLE HEART LEAD EXTENDER
K790468 · Arco Medical Products Co. · Mar 1979