Cleared Traditional

K914208 - MERIT DISPOSAL DEPOT(TM)

K914208 is an FDA 510(k) clearance for MERIT DISPOSAL DEPOT(TM), manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914208 · Merit Medical Systems, Inc. · Cardiovascular device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914208 is an FDA 510(k) clearance for the MERIT DISPOSAL DEPOT(TM). Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 18, 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 870.1200 - 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K914208

510(k) Number K914208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date December 18, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K914208.
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ANGIOGRAPHIC SOFT TIP CATHETER
K914199 · E-Z-Em, Inc. · Dec 1991
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH
K912532 · Interventional Therapeutics Corp. · Dec 1991
RETRIEVAL DEVICE
K914067 · Target Therapeutics · Dec 1991
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER
K914009 · Schneider Intl., Ltd. · Dec 1991