Cleared Traditional

K813205 - INTERSEPT CARDIOTOMY RESERVOIR/FILTER

K813205 is the FDA 510(k) clearance for INTERSEPT CARDIOTOMY RESERVOIR/FILTER by Extracorporeal Medical Specialities, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K813205 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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Jan 1982
Decision
76d
Days
Class 3
Risk

K813205 is an FDA 510(k) clearance for the INTERSEPT CARDIOTOMY RESERVOIR/FILTER. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K813205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1981
Decision Date January 28, 1982
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 273
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K813205.
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · Pacesetter Systems · Aug 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · Intermedics, Inc. · Apr 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · Telectronics, Inc. · Feb 1982
POLY-FLEX PACING LEADS
K813028 · Intermedics, Inc. · Dec 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP
K813134 · Telectronics, Inc. · Dec 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · Pacesetter Systems · Nov 1981