Cleared Traditional

K980104 - FLOW RIDER FLOW DIRECTED MICRO CATHETER

K980104 is an FDA 510(k) clearance for FLOW RIDER FLOW DIRECTED MICRO CATHETER, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K980104 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
88d
Days
Class 2
Risk

K980104 is an FDA 510(k) clearance for the FLOW RIDER FLOW DIRECTED MICRO CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 10, 1998 after a review of 88 days - a notably fast clearance 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: 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 Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K980104

510(k) Number K980104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1998
Decision Date April 10, 1998
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 139
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K980104.
PROWLER PLUS INFUSION CATHETER
K993266 · Cordis Neurovascular, Inc. · Oct 1999
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · Cordis Neurovascular, Inc. · Sep 1998
EASY RIDER MICRO CATHETER
K974473 · Micro Therapeutics, Inc. · Jun 1998
MICROFUSE MEMBRANE INFUSION CATHETER
K971619 · E-Med Corp. · Feb 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997