Cleared Traditional

K972017 - BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)

K972017 is an FDA 510(k) clearance for BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOC..., manufactured by Minntech Corp.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K972017 · Minntech Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
103d
Days
Class 2
Risk

K972017 is an FDA 510(k) clearance for the BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR). Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 10, 1997 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 870.4400 - 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 Minntech Corp. devices

FDA 510(k) Submission Details - K972017

510(k) Number K972017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date September 10, 1997
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
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.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 146
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K972017.
CAPIOX SX HARDSHELL RESERVOIR
K980935 · Terumo Medical Corp. · May 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155 · Baxter Healthcare Corp · Jan 1998
CHASE TEMPERATURE PROBE
K971013 · Chase Medical, Inc. · Oct 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · Sorin Biomedical, Inc. · Sep 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
K964907 · Sorin Biomedical, Inc. · Aug 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669 · Cobe Cardiovascular, Inc. · Jul 1997