← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K970259 # E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET (K970259) _Becton Dickinson Vascular Access, Inc. · FPA · Apr 8, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970259 ## Device Facts - **Applicant:** Becton Dickinson Vascular Access, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Apr 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure. ## Device Story Single-use intravascular administration set; stainless steel needle with butterfly wings and short extension set; provides vascular access for fluid administration, blood sampling, and blood pressure monitoring; used in clinical settings by healthcare professionals. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Stainless steel needle; butterfly wings; short extension set; single-use; sterile. ## Regulatory Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Predicate Devices - Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® infusion sets ## 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} K970259 April 8, 1997 # SUMMARY OF SAFETY AND EFFICACY A. The submitter’s name, address, telephone number, contact person, and date of preparation. Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: January 22, 1997 B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name. Name: Intravascular Administration Set Brand: E-Z SET® and Saf-T E-Z SET® Infusion Sets Common Name: Infusion Set Classification Name: Intravascular Administration Set (80 FPA) C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed: Predicate Device: The Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® brand infusion sets. D. A description of the device that is the subject of the Premarket Notification submission. The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set. E. Statement of intended use of the device. The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure. F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above. The proposed infusion sets differ from the E-Z SET® and SAF-T E-Z SET® brand infusion sets currently marketed in that the intended use clarifies the suitability for additional uses. The device is unchanged. 002 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970259](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970259) **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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