Perma-Pass Vascular Graft, 6S Graft, Model 31453, 6T Graft, Model 31452

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K984182 ↗

FDA Product Code

DSY

Models / Variants

31453

6T Graft

Model 31452

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Guarddog Occlusion System

  Class II

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• Fetch Aspiration Catheter

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• Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002

  Class II

  FDA 510(k) K993564 Active Cleared 28 Apr 2000

• Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039

  Class II

  FDA 510(k) K071342 Active Cleared 31 Jul 2007

• Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001

  Class II

  FDA 510(k) K090253 Active Cleared 8 Apr 2009

• Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

  Class II

  FDA 510(k) K040013 Active Cleared 18 May 2004

See all devices from Possis Medical, Inc. →

• What are the primary uses for the Perma-Pass Vascular Graft in surgical procedures?

  The Perma-Pass Vascular Graft is designed specifically for use as a bypass graft in cardiovascular surgeries. It is intended to replace or bypass damaged or occluded blood vessels, helping to restore proper blood flow in critical areas of the body.

• Is the Perma-Pass Vascular Graft intended for single-use or can it be reused?

  The Perma-Pass Vascular Graft is supplied sterile and explicitly intended for single-use in surgical settings. Reuse is not recommended or supported by the manufacturer.

• What sizes are available for the Perma-Pass Vascular Graft, and how do I identify the correct model?

  The Perma-Pass Vascular Graft comes in two sizes: a 6S Graft (Model 31453) and a 6T Graft (Model 31452). Both are designed with a diameter of 6 mm or greater, making them suitable for larger vascular bypass procedures. The model number helps distinguish between the two variants.

• How is the Perma-Pass Vascular Graft regulated in the U.S., and what does that mean for clinicians?

  The Perma-Pass Vascular Graft is regulated under the FDA’s 510(k) clearance process (K984182) and classified as a Class II medical device under product code DSY. This means it has undergone review by the FDA’s Cardiovascular (CV) Advisory Committee and was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for vascular grafts.

• How should the Perma-Pass Vascular Graft be stored, and what does the sterile packaging imply for surgical preparation?

  The Perma-Pass Vascular Graft is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. Clinicians should follow standard sterile field protocols when handling the graft, ensuring it remains uncontaminated until implantation. The single-use nature also implies that opened or exposed grafts should not be reused.