VASCUTEK GRAFT SIZER SET
Device Facts
| Record ID | K955588 |
|---|---|
| Device Name | VASCUTEK GRAFT SIZER SET |
| Applicant | Carbomedics, Inc. |
| Product Code | DSY · Cardiovascular |
| Decision Date | Mar 7, 1996 |
| Decision | ST |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3450 |
| Device Class | Class 2 |
Intended Use
The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.
Device Story
Vascutek Graft Sizer Set consists of nine double-ended 'C' shaped sizers; size range 5-32 mm. Used by surgeons in clinical/OR settings to match vascular graft diameter to artery diameter. Surgeon manually selects sizer that best fits outside of vessel; corresponding number on sizer indicates required graft size. Facilitates accurate graft selection; aids surgical decision-making; improves procedural efficiency.
Clinical Evidence
Bench testing only. Biocompatibility testing confirmed material is non-hemolytic, non-cytotoxic, non-pyrogenic, and meets USP Class VI-50 requirements.
Technological Characteristics
Nine double-ended 'C' shaped sizers; size range 5-32 mm. Material meets USP Class VI-50 standards. Supplied sterile; single-use only.
Indications for Use
Indicated for use by surgeons to assist in sizing vascular grafts to match the patient's artery during vascular surgery.
Regulatory Classification
Identification
A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Predicate Devices
- Meadox Graft Sizer (K854431)
Related Devices
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- K022242 — INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER · Intervascular · Aug 14, 2002
- K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe · Fehling Surgical Instruments, Inc. · Apr 20, 2023
- K190499 — Gem FlowCoupler System · Baxter/ Synovis Micro Companies Alliance, Inc. · Sep 6, 2019
- K162448 — White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter · Cook Incorporated · May 26, 2017
