Cleared Traditional

K911870 - SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH

K911870 is an FDA 510(k) clearance for SCIMED OPTAMUM OPERATIVE PERIPHERAL ANG..., 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 108-day FDA review.

K911870 · Scimed Life Systems, Inc. · Cardiovascular device
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Aug 1991
Decision
108d
Days
Class 2
Risk

K911870 is an FDA 510(k) clearance for the SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 108 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K911870

510(k) Number K911870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date August 12, 1991
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K911870.
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH
K912317 · Schneider Intl., Ltd. · Aug 1991
OPTI-PLAST 5F PTA CATHETERS
K913112 · Vas-Cath, Inc. · Aug 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K912984 · Vas-Cath, Inc. · Aug 1991
CORDIS OPTA 5
K905698 · Cordis Corp. · Jul 1991
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE
K911639 · Vas-Cath, Inc. · Jun 1991
SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)
K911196 · Schneider Intl., Ltd. · Jun 1991