Cleared Special

K991027 - BI-DIRECTIONAL TUNNELER

K991027 is an FDA 510(k) clearance for BI-DIRECTIONAL TUNNELER, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 24-day FDA review.

K991027 · Impra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
24d
Days
Class 2
Risk

K991027 is an FDA 510(k) clearance for the BI-DIRECTIONAL TUNNELER. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on April 22, 1999 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Impra, Inc. devices

FDA 510(k) Submission Details - K991027

510(k) Number K991027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date April 22, 1999
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 128
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K991027.
ADVANTA GRAFT
K992443 · Atrium Medical Corp. · Aug 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc. · Jul 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · Atrium Medical Corp. · Jun 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · Possis Medical, Inc. · Feb 1999
DISTAFLO BYPASS GRAFT
K983861 · Impra, Inc. · Nov 1998
IMPRA HIGH POROSITY GRAFT
K983064 · Impra, Inc. · Nov 1998