Cleared Traditional

K130161 - PASSEO-35

K130161 is an FDA 510(k) clearance for PASSEO-35, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K130161 · Biotronik, Inc. · Cardiovascular device
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Apr 2013
Decision
90d
Days
Class 2
Risk

K130161 is an FDA 510(k) clearance for the PASSEO-35. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 23, 2013 after a review of 90 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 Biotronik, Inc. devices

FDA 510(k) Submission Details - K130161

510(k) Number K130161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date April 23, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 285
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K130161.
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