Cleared Traditional

K973477 - BIOSENSORS EMBOLECTOMY CATHETER

K973477 is an FDA 510(k) clearance for BIOSENSORS EMBOLECTOMY CATHETER, manufactured by Sunscope Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K973477 · Sunscope Intl., Inc. · Cardiovascular device
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Sep 1998
Decision
354d
Days
Class 2
Risk

K973477 is an FDA 510(k) clearance for the BIOSENSORS EMBOLECTOMY CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Sunscope Intl., Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sunscope Intl., Inc. devices

FDA 510(k) Submission Details - K973477

510(k) Number K973477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1997
Decision Date September 04, 1998
Days to Decision 354 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
229d slower than avg
Panel avg: 125d · This submission: 354d
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 56
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K973477.
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934 · Vascutech, Inc. · Mar 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · Vascutech, Inc. · Feb 2000
LEMAITRE EMBOLECTOMY CATHETER
K992368 · Vascutech, Inc. · Dec 1999
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · Arrow Intl., Inc. · Aug 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · AngioDynamics, Inc. · Mar 1998
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511 · Microvena Corp. · Mar 1998