Cleared Traditional

K991093 - MSD EMBOLECTOMY BASKET

K991093 is an FDA 510(k) clearance for MSD EMBOLECTOMY BASKET, manufactured by Metamorphic Surgical Devices, LLC. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 630-day FDA review.

K991093 · Metamorphic Surgical Devices, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
630d
Days
Class 2
Risk

K991093 is an FDA 510(k) clearance for the MSD EMBOLECTOMY BASKET. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Metamorphic Surgical Devices, LLC (Pittsburgh, US). The FDA issued a Cleared decision on December 21, 2000 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Metamorphic Surgical Devices, LLC devices

FDA 510(k) Submission Details - K991093

510(k) Number K991093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date December 21, 2000
Days to Decision 630 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
505d slower than avg
Panel avg: 125d · This submission: 630d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
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.