Cleared Traditional

K841961 - MILLS OPERATIVE PERIPHERAL ANGIOPLASTY

K841961 is the FDA 510(k) clearance for MILLS OPERATIVE PERIPHERAL ANGIOPLASTY by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 243
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