Cleared Traditional

K841961 - MILLS OPERATIVE PERIPHERAL ANGIOPLASTY

K841961 is an FDA 510(k) clearance for MILLS OPERATIVE PERIPHERAL ANGIOPLASTY, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K841961 · Scimed Life Systems, Inc. · Cardiovascular device
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Oct 1984
Decision
162d
Days
Class 2
Risk

K841961 is an FDA 510(k) clearance for the MILLS OPERATIVE PERIPHERAL ANGIOPLASTY. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 162 days - an extended review cycle.

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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K841961

510(k) Number K841961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date October 23, 1984
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 347
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K841961.
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · Scimed Life Systems, Inc. · Apr 1985
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · Advanced Cardiovascular Systems, Inc. · Nov 1984
MEDI-TECH DILATATION CATHETERS
K843383 · Medi-Tech, Inc. · Oct 1984
BALLOON DILATION CATHETER
K843501 · Advanced Cardiovascular Systems, Inc. · Oct 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
K834429 · American Edwards Laboratories · Aug 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · Advanced Cardiovascular Systems, Inc. · Aug 1984