Cleared Special

K250706 - Passeo-35 Xeo Peripheral Dilatation Catheter (FDA 510(k) Clearance)

Also includes:
Passeo-18 Peripheral Dilatation Catheters Passeo-14 Peripheral Dilatation Catheter Oscar Peripheral Multifunctional Catheter System Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250706 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
25d
Days
Class 2
Risk

K250706 is an FDA 510(k) clearance for the Passeo-35 Xeo Peripheral Dilatation Catheter. 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 4, 2025 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K250706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date April 04, 2025
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 401
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K250706.
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