Cleared Traditional

K812502 - IMPLANTAID LEAD INTRODUCER #319-10 & 12

K812502 is an FDA 510(k) clearance for IMPLANTAID LEAD INTRODUCER #319-10 & 12, manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K812502 · Intermedics, Inc. · Cardiovascular device
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Oct 1981
Decision
42d
Days
Class 2
Risk

K812502 is an FDA 510(k) clearance for the IMPLANTAID LEAD INTRODUCER #319-10 & 12. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics, Inc. devices

FDA 510(k) Submission Details - K812502

510(k) Number K812502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1981
Decision Date October 13, 1981
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 439
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K812502.
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
NEONATAL INTRODUCER KIT
K820710 · Norton Performance Plastics Corp. · Apr 1982
NORTON JUGULAR KITS
K820581 · Norton Performance Plastics Corp. · Mar 1982
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · Sorensen Research · Sep 1981
PERMANENT LEAD INTRADUCER
K800356 · Daig Corp. · May 1980
THERMODILUTION CATHETER INTRO. KIT
K800619 · Norton Performance Plastics Corp. · Apr 1980