Cleared Traditional

K800353 - ADAPTER KIT

K800353 is the FDA 510(k) clearance for ADAPTER KIT by Daig Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 85
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
ELECTRODE, MODEL 030-324
K781822 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-326
K781823 · Telectronics, Inc. · Feb 1979