Cleared Traditional

K913517 - ISOLATE INFUSION CATHETR SYSTEM

K913517 is an FDA 510(k) clearance for ISOLATE INFUSION CATHETR SYSTEM, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913517 · Lake Region Mfg., Inc. · Cardiovascular device
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Nov 1991
Decision
90d
Days
Class 2
Risk

K913517 is an FDA 510(k) clearance for the ISOLATE INFUSION CATHETR SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K913517

510(k) Number K913517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1991
Decision Date November 05, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K913517.
CORDIS SHUTTLE CATHETER
K915777 · Cordis Corp. · Feb 1992
ITC GUIDING CATHETER
K913052 · Interventional Therapeutics Corp. · Nov 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · Scimed Life Systems, Inc. · Nov 1991
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K913783 · Dow Corning Wright · Oct 1991
RIGHT ATRIAL CATHETERS
K911333 · Akcess Medical Products, Inc. · Sep 1991
PROFUSE INFUSION SYSTEM
K912877 · Lake Region Mfg., Inc. · Sep 1991