Cleared Traditional

K964112 - BERENSTEIN COIL

K964112 is an FDA 510(k) clearance for BERENSTEIN COIL, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K964112 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
134d
Days
Class 2
Risk

K964112 is an FDA 510(k) clearance for the BERENSTEIN COIL. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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 Target Therapeutics devices

FDA 510(k) Submission Details - K964112

510(k) Number K964112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date February 26, 1997
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 121
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K964112.
CONTOUR SE MICROSPHERES
K034068 · Boston Scientific Corp · Mar 2004
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · Cook, Inc. · Jan 2000
EMBOLIZATION COIL SYSTEM
K992121 · Cook, Inc. · Dec 1999
FIBERED PLATINUM COIL, .035 TYPE
K955293 · Target Therapeutics · Feb 1996
COIL POSITIONER SET
K940189 · Cook, Inc. · Nov 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · Cook, Inc. · Oct 1994