← Product Code [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL) · K963749 # HIGH PRESSURE INJECTION LINES (K963749) _Maxxim Medical · DTL · Dec 17, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K963749 ## Device Facts - **Applicant:** Maxxim Medical - **Product Code:** [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL.md) - **Decision Date:** Dec 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4290 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Intended Use Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices. ## Device Story High pressure injection line; conduit tubing for fluid delivery from electronic/manual injectors; connector tubing for sterile fluid pathways between devices. Consists of plastic tubing with female/male or female/rotating male luer lock connector hubs. Lengths 10-48 inches. Supplied sterile/disposable, non-sterile bulk, or as component in catheter introducer kits/trays. Used in clinical settings; operated by healthcare professionals. Facilitates fluid transfer; ensures sterile connection between devices. ## Clinical Evidence Bench testing only. Biocompatibility established via cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and hemocompatibility tests. Meets USP XXIII physico-chemical requirements for plastics. Performance verified via simulated use, pull tests, and static pressure tests. ## Technological Characteristics Plastic tubing with luer lock connector hubs (female/male or female/rotating male). Lengths 10-48 inches. Biocompatibility per USP XXIII. Sterilization method not specified. ## Regulatory Identification A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Predicate Devices - Advance High Pressure Lines ([K911884](/device/K911884.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} K963749 # 510 (k) SUMMARY ## I. ADMINISTRATIVE Submitter: Maxxim Medical, Inc., Argon Division 1445 Flat Creek Road Athens, TX 75751 (903) 675-9321 Contact Person: Eddie Monroe Date of Preparation: September 9, 1996 ![img-0.jpeg](img-0.jpeg) ## II. DEVICE NAME Proprietary Name: None Common Name: High Pressure Injection Line Classification Name: Cardiopulmonary bypass adaptor, stopcock, manifold or fitting ## III. PREDICATE DEVICE Advance High Pressure Lines; K911884; Advance Medical, Inc. ## IV. DEVICE DESCRIPTION The High Pressure Line is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. The device consists of plastic tubing with plastic luer lock connector hubs at each end. The luer lock connector hubs are a female/male combination or a female/rotating male combination. The device is available in lengths of 10 to 48 inches and supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits, trays, or packs. Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests. The device meets the requirements of the USP XXIII physico-chemical tests for plastics. ## V. INTENDED USE Conduit tubing to deliver fluids from an electronic or manual injector; connector tubing to provide a sterile fluid pathway between two devices. Premarket Notification: High Pressure Inject. in tine {1} 11 # VI. COMPARISON TO PREDICATE DEVICE The High Pressure Injection Line is similar in design and composition, and identical in function and intended use to the High Pressure Line (Advance Medical; K911884). Results of simulated use tests, pull tests and static pressure tests indicate that the High Pressure Injection Line has performance characteristics equivalent to or better than those of the predicate device. Accordingly, Maxxim Medical, Inc., Argon Division, concluded that the High Pressure Injection Line is safe and effective for its intended use and performs at least as well as the legally marketed predicate device. Premarket Notification: High Pressure Injection --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K963749](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K963749) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com