Cleared Traditional

K982141 - ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER

K982141 is an FDA 510(k) clearance for ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K982141 · Arrow Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
75d
Days
Class 2
Risk

K982141 is an FDA 510(k) clearance for the ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K982141

510(k) Number K982141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date August 31, 1998
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 36
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