Cleared Traditional

Sniper Infusion Catheter with Balloon Occlusion (K180904) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180904 · Embolx, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2018
Decision
63d
Days
Class 2
Risk

K180904 is an FDA 510(k) clearance for the Sniper Infusion Catheter with Balloon Occlusion. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Embolx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 8, 2018 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Embolx, Inc. devices

Submission Details

510(k) Number K180904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2018
Decision Date June 08, 2018
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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

Third Party Review Group, LLC
DAVE YUNGVIRT

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 - MJN Catheter, Intravascular Occluding, Temporary

All 24
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K180904.
Eclipse 2L
K183045 · Balt USA, LLC · Apr 2019
Occlusion Balloon Catheter
K183679 · Qxmedical, LLC · Apr 2019
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916 · Lemaitre Vascular · Nov 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · W. L. Gore and Associates, Inc. · Jan 2018
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014