Cleared Special

K093139 - BANTAM,48XXXXXX, 50XXXXXX

K093139 is an FDA 510(k) clearance for BANTAM, manufactured by ClearStream Technologies , Ltd.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 86-day FDA review.

K093139 · ClearStream Technologies , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
86d
Days
Class 2
Risk

K093139 is an FDA 510(k) clearance for the BANTAM,48XXXXXX, 50XXXXXX. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by ClearStream Technologies , Ltd. (Wexford, IE). The FDA issued a Cleared decision on December 30, 2009 after a review of 86 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.

FDA 510(k) Submission Details - K093139

510(k) Number K093139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2009
Decision Date December 30, 2009
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 397
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K093139 · BANTAM,48XXXXXX, 50XXXXXX
Download PDF FDA Summary ClearStream Technolog…