Cleared Traditional

K870413 - PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)

K870413 is an FDA 510(k) clearance for PERCUTANEOUS SHEATH W/WO MEDI. (5, manufactured by Medical Surgical Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K870413 · Medical Surgical Concepts, Inc. · Cardiovascular device
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Jun 1987
Decision
118d
Days
Class 2
Risk

K870413 is an FDA 510(k) clearance for the PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR). Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Medical Surgical Concepts, Inc. (Lansdale, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Medical Surgical Concepts, Inc. devices

FDA 510(k) Submission Details - K870413

510(k) Number K870413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date June 01, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 87
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K870413.
DAIG VESSEL DILATOR
K894330 · Daig Corp. · Sep 1989
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988
10 AND 12 FRENCH VESSEL DILATORS
K874738 · Impra, Inc. · May 1988
URESIL CAROTID ARTERY SIZERS
K871148 · Uresil Corp. · Apr 1987
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · Mallinckrodt Critical Care · Jul 1984