Cleared Special

Instylla Microcatheter 1.2 (K210808) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210808 · Instylla, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
29d
Days
Class 2
Risk

K210808 is an FDA 510(k) clearance for the Instylla Microcatheter 1.2. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on April 15, 2021 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instylla, Inc. devices

Submission Details

510(k) Number K210808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2021
Decision Date April 15, 2021
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 67
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K210808.
PROWLER SELECT PLUS
K210838 · Medos International SARL · Aug 2021
Bullfrog Micro-Infusion Device
K210339 · Mercator Medsystems, Inc. · Aug 2021
SwiftNINJA Steerable Microcatheter
K211525 · Merit Medical Systems, Inc. · Jul 2021
Rebar Micro Catheter
K210114 · Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · Feb 2021
MAGIC Infusion Catheter
K202366 · Balt USA, LLC · Jan 2021
Marathon Flow Directed Micro Catheter
K202318 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Sep 2020