Cleared Traditional

K994155 - EXCELSIOR 1018 MICROCATHETER

K994155 is an FDA 510(k) clearance for EXCELSIOR 1018 MICROCATHETER, manufactured by Boston Scientific, Target. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K994155 · Boston Scientific, Target · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
238d
Days
Class 2
Risk

K994155 is an FDA 510(k) clearance for the EXCELSIOR 1018 MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on August 3, 2000 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Boston Scientific, Target devices

FDA 510(k) Submission Details - K994155

510(k) Number K994155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date August 03, 2000
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 133
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K994155.
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · Micro Therapeutics, Inc. · Feb 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · Cordis Neurovascular, Inc. · Jan 2001
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · Micro Therapeutics, Inc. · Sep 2000
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
K001966 · Micro Therapeutics, Inc. · Jul 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · Micro Therapeutics, Inc. · Jan 2000