Cleared Traditional

K121734 - PLATO MICROCATH 27 MICROCATHETER

K121734 is an FDA 510(k) clearance for PLATO MICROCATH 27 MICROCATHETER, manufactured by Scientia Vascular, LLC. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K121734 · Scientia Vascular, LLC · Cardiovascular device
Download Printable Device Report (PDF)
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Jul 2012
Decision
47d
Days
Class 2
Risk

K121734 is an FDA 510(k) clearance for the PLATO MICROCATH 27 MICROCATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scientia Vascular, LLC (Salt Lake City, US). The FDA issued a Cleared decision on July 30, 2012 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Scientia Vascular, LLC devices

FDA 510(k) Submission Details - K121734

510(k) Number K121734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2012
Decision Date July 30, 2012
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 425
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K121734.
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