Cleared Traditional

VIVO (K183195) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K183195 · Catheter Precision, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
207d
Days
Class 2
Risk

K183195 is an FDA 510(k) clearance for the VIVO. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Catheter Precision, Inc. (Ledgewood, US). The FDA issued a Cleared decision on June 14, 2019 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Catheter Precision, Inc. devices

Submission Details

510(k) Number K183195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date June 14, 2019
Days to Decision 207 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
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03340142 Completed Interventional Industry-sponsored

VIVO™ Accuracy Study

45
Patients (actual)
3
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Premature Ventricular Contraction; Ventricular Tachycardia
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Missiaen Huck
Sponsor Catheter Precision. Inc. (industry)
Started 2018-01-29 → Primary completion 2018-09-04 → Completed 2018-11-01
Primary outcome
Accuracy of correctly identifying PVC or VT origin
Secondary outcome
Accuracy of correctly identifying known pacing sites
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 427
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