Cleared Traditional

K100842 - PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

K100842 is an FDA 510(k) clearance for PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, manufactured by Hotspur Technologies. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K100842 · Hotspur Technologies · Cardiovascular device
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Jul 2010
Decision
109d
Days
Class 2
Risk

K100842 is an FDA 510(k) clearance for the PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Hotspur Technologies (Mountain View, US). The FDA issued a Cleared decision on July 12, 2010 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Hotspur Technologies devices

FDA 510(k) Submission Details - K100842

510(k) Number K100842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2010
Decision Date July 12, 2010
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 43
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