Cleared Traditional

K833248 - LOW PROFILE STEERABLE-INTRAOPERATIVE

K833248 is the FDA 510(k) clearance for LOW PROFILE STEERABLE-INTRAOPERATIVE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K833248 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 1983
Decision
98d
Days
Class 2
Risk

K833248 is an FDA 510(k) clearance for the LOW PROFILE STEERABLE-INTRAOPERATIVE. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 98 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K833248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date December 22, 1983
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K833248.
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · Advanced Cardiovascular Systems, Inc. · Aug 1984
HYBRID PERIPHERAL DILATION CATHETER
K834220 · American Edwards Laboratories · Jan 1984
OLBERT CATHETER SYSTEM
K833616 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
K832474 · American Edwards Laboratories · Sep 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · American Edwards Laboratories · Aug 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · Advanced Cardiovascular Systems, Inc. · Jun 1983