Cleared Traditional

K925283 - VALVULOTOME

K925283 is an FDA 510(k) clearance for VALVULOTOME, manufactured by Intramed Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 478-day FDA review.

K925283 · Intramed Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
478d
Days
Class 2
Risk

K925283 is an FDA 510(k) clearance for the VALVULOTOME. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Intramed Laboratories, Inc. devices

FDA 510(k) Submission Details - K925283

510(k) Number K925283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date February 10, 1994
Days to Decision 478 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 125d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MGZ Device Classification - Class 2, Special Controls

Product Code MGZ Valvulotome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
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 - MGZ Valvulotome

All 17
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K925283.
FOGARTY VALVULOTOME, MODEL 700091
K001734 · Edwards Lifesciences, LLC · Mar 2001
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · Vascutech, Inc. · Feb 1999
FOGARTY VALVULOTOME MODEL 700091
K965137 · Baxter Edwards · Jun 1997
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011 · Uresil Corp. · May 1993
SCANLAN/TAHERI VALVULOTOME
K911184 · Scanlan Intl., Inc. · Feb 1992
OLYMPUS RETRACTABLE VALVULOTOME
K911702 · Olympus Corp. · Dec 1991