Cleared Traditional

K840756 - BIOPATCH BOVINE PERICARDIAL PATCH

K840756 is an FDA 510(k) clearance for BIOPATCH BOVINE PERICARDIAL PATCH, manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K840756 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
351d
Days
Class 2
Risk

K840756 is an FDA 510(k) clearance for the BIOPATCH BOVINE PERICARDIAL PATCH. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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. Elevated predicate reliance 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 Meadox Medicals, Div. Boston Scientific Corp. devices

FDA 510(k) Submission Details - K840756

510(k) Number K840756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date February 08, 1985
Days to Decision 351 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
226d slower than avg
Panel avg: 125d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 703
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K840756.
WIRE, GUIDE - MODIFICATION
K850828 · Lake Region Mfg., Inc. · Jun 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · Advanced Cardiovascular Systems, Inc. · Jun 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · Advanced Cardiovascular Systems, Inc. · Jun 1985
HYDROGLIDE SPRING GUIDE WIRES
K841926 · Argon Medical Corp. · Jan 1985
WIREGUIDE OR GUIDEWIRE
K843012 · Medi-Tech, Inc. · Nov 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984