Cleared Traditional

K201445 - MultiCath

K201445 is the FDA 510(k) clearance for MultiCath by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K201445 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
458d
Days
Class 2
Risk

K201445 is an FDA 510(k) clearance for the MultiCath, AcQRate Dx Fixed Curve Catheter. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 2, 2021 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K201445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date September 02, 2021
Days to Decision 458 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
333d slower than avg
Panel avg: 125d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 97
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K201445.
ViaCath, AcQRate Dx Steerable Catheter
K212593 · Biotronick, Inc. · Oct 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · Boston Scientific Corporation · Sep 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · Boston Scientific Corporation · Sep 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · Innovative Health, LLC · Mar 2021
LassoStar Circular Mapping Catheter
K193632 · Biosense Webster, Inc. · Jun 2020
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
K191880 · Innovative Health, LLC · Dec 2019