The World's Thinnest, Strongest, and Smallest Heat Shrink Tubing

Custom and Stock Medical Balloons

Serving the Medical Device Industry since 1989

ISO 13485:2003 Registered

Medical Balloons

Technical Information

Standard Cylindrical Balloon

Balloon Definitions/Terms

Standard Balloon Ends

Biocompatibility

Bonding PET Balloons

Thermal Bonding Urethane and Other Balloon Materials

Medical Balloons - Technical Information - Biocompatibility

Material:	PET
Raw Material #:	114-0001
Conducted By:	North American Scientific Associates, Inc. (NAmSA^®)
Test Data:	Biocompatibility Test Data (PET # 114-0001)

Biocompatibility Test Summary

	Study	Project Number	Result
1	USP Systemic Toxicity Study in the Mouse (Extracts)	TU012-500	Pass
2	USP Intracutaneous Toxicity Study in the Rabbit (Extracts)	TU013-800	Pass
3	USP Muscle Implantation Study in Rabbit (5 day)	TU014-805	Pass
4	Rabbit Pyrogen Study (Material Mediated)	TU010-807	Pass
5	Cytotoxicity Study Using the ISO Elution Method	MG064-100	Pass
6	Hemolysis Study – In Vitro Procedure (Extraction Method)	MG074-100	Pass

Material:	PET
Raw Material #:	114-0002
Conducted By:	North American Scientific Associates, Inc. (NAmSA^®)
Test Data:	Biocompatibility Test Data (PET # 114-0002)

Biocompatibility Test Summary

	Study	Project Number	Result
1	USP Systemic Toxicity Study in the Mouse (Extracts)	TU012-500	Pass
2	USP Intracutaneous Toxicity Study in the Rabbit (Extracts)	TU013-800	Pass
3	USP Muscle Implantation Study in Rabbit (5 day)	TU014-805	Pass
4	Rabbit Pyrogen Study (Material Mediated)	TU010-807	Pass
5	Cytotoxicity Study Using the ISO Elution Method	MG064-100	Pass
6	Hemolysis Study – In Vitro Procedure (Extraction Method)	MG074-100	Pass

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