← Product Code [DSY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY) · K955588 # VASCUTEK GRAFT SIZER SET (K955588) _Carbomedics, Inc. · DSY · Mar 7, 1996 · Cardiovascular · ST_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K955588 ## Device Facts - **Applicant:** Carbomedics, Inc. - **Product Code:** [DSY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY.md) - **Decision Date:** Mar 7, 1996 - **Decision:** ST - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.3450 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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](/device/K854431.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} CarboMedics A company of BULZERmedica K955588 1300 EAST ANDERSON LANE, AUSTIN, TEXAS 78752-1793 510(k) Summary Trade Name: Vascutek Graft Sizer Set Common Name: Graft Sizer December 6, 1995 The Vascutek Graft Sizer Set consists of nine individual double-ended 'C' shaped graft sizers. The nine sizers are secured within a clip and are available in a size range from 5 to 32 mm. The graft sizers are supplied sterile and are for single use only. 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. Biocompatibility tests conducted on the finished device showed that the material is non-hemolytic, non-cytotoxic, and non-pyrogenic. In addition, extensive biocompatibility testing conducted on the material demonstrates its suitability for medical uses in devices and packaging. In addition, it has been shown that the material meets the requirements of USP Class VI-50, being compatible with blood and demonstrating no cytotoxic, mutagenic, or irritant potential. CarboMedics considers the Vascutek Graft Sizer Set to be equivalent in intended use, composition, design, and function to the Meadox Graft Sizer manufactured by Meadox Medical, Inc. Marketing clearance was granted by the FDA for 510(k) number K854431 on May 7, 1986, for the Meadox Graft Sizer. Contact Person: Edward E. Newton Regulatory Affairs Specialist CarboMedics, Inc. 1300 East Anderson Lane Austin, TX 78752 Phone: (512) 435-3407 Fax: (512) 435-3350 ii PH: (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US AND CANADA) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K955588](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K955588) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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