Cleared Traditional

K812221 - INTERMEDICS POLY FLEX EPICARDIAL SUTURE

K812221 is an FDA 510(k) clearance for INTERMEDICS POLY FLEX EPICARDIAL SUTURE, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K812221 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
60d
Days
Class 3
Risk

K812221 is an FDA 510(k) clearance for the INTERMEDICS POLY FLEX EPICARDIAL SUTURE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981 after a review of 60 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K812221

510(k) Number K812221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1981
Decision Date October 06, 1981
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K812221.
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · Pacesetter Systems · Oct 1981
MEDTRONIC #4951
K812599 · Medtronic Vascular · Oct 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593 · Telectronics, Inc. · Oct 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · Intermedics, Inc. · Oct 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · Pacesetter Systems · Aug 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · Biotronik Sales, Inc. · Aug 1981