Cleared Traditional

K230706 - EMBOLD™ Soft Detachable Coil System

K230706 is an FDA 510(k) clearance for EMBOLD Soft Detachable Coil System, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K230706 · Boston Scientific Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
105d
Days
Class 2
Risk

K230706 is an FDA 510(k) clearance for the EMBOLD™ Soft Detachable Coil System. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Boston, US). The FDA issued a Cleared decision on June 27, 2023 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K230706

510(k) Number K230706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2023
Decision Date June 27, 2023
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 120
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K230706.
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