← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K960406 # BRAUN HEMOSTASIS INTRODUCERS (K960406) _B.Braun Medical, Inc. · DYB · Apr 12, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K960406 ## Device Facts - **Applicant:** B.Braun Medical, Inc. - **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md) - **Decision Date:** Apr 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. ## Device Story Braun Hemostasis Introducer Kits consist of hemostasis valve introducer sheath, dilator, and optional guidewire/obturator. Used by physicians in clinical settings to facilitate percutaneous catheter insertion into vasculature. Sheath design prevents blood backflow during procedure. Available in straight and contralateral curve configurations, 5-9 French sizes, 10-60 cm lengths. Device provides access path for diagnostic or interventional catheters; enables clinician to maintain vascular access while minimizing blood loss. ## Clinical Evidence Bench testing only. Performance metrics include: hub-to-body tensile strength (14.5-18.4 lbs), shape recovery (85-88%), kink resistance (no kinks at 170° for 5F), and leak testing (no leaks at 100 psi for sheath, 6 psi for gasket). ## Technological Characteristics Materials: PEBA sheath. Construction: Braided body. Sizes: 5-9 French. Lengths: 10-60 cm. Configurations: Straight and contralateral curve. Features: Hemostasis valve, dilator, optional guidewire/obturator. Energy source: None (mechanical). ## Regulatory Identification A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. ## Predicate Devices - Balkin Up & Over Cook ([K895044](/device/K895044.md)) - Braun Fluoro-Tip™ Hemostasis Introducer Kits ([K945396](/device/K945396.md)) ## Reference Devices - Braun 510(k) [K894446](/device/K894446.md) - Braun 510(k) [K930057](/device/K930057.md) - Braun 510(k) [K931743](/device/K931743.md) - Braun 510(k) [K950882](/device/K950882.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} K960406 # II. SUMMARY OF SAFETY AND EFFECTIVENESS Applicant Name & Address: B. Braun Medical Inc., Cardiovascular Division, 13000 Hwy 55 Minneapolis, MN 55441-3813 (612) 559-3370 Contact: Barbara Atzenhoefer, Regulatory Affairs Manager Date Prepared: January 22, 1996 Common or Usual Name: Braun Hemostasis Introducer Kits Device Classification Name: Catheter Introducer ## Substantial Equivalence: K895044* Balkin Up & Over Cook K945396 Braun Fluoro-Tip™ Hemostasis Introducer Kits B. Braun Cardiovascular Device Description: Braun Hemostasis Introducer Kits consist of a hemostasis valve introducer sheath packaged with a corresponding dilator. One or more of the following accessories may also be packaged with the sheath/dilator; guidewire, and/or obturator. The introducer sheaths are available in both straight and contralateral curve versions. They will be available in 5 - 9 French sizes, in lengths from 30 - 60 cm in the curved version and 10 - 60 cm in the straight version. Each will be packaged with an appropriately sized dilator. Optional items to be kitted with the sheath and dilator include a guidewire, and/or obturator. The components, their materials and accessories, are similar to those previously cleared under Braun 510(k)s; K894446, K930057, K931743, K945396, and K950882. Statement of Intended Use: The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. Summary/Comparison of Technological Characteristics: | Characteristic | Braun Hemostasis Introducer Kits | Cook Up & Over Balkin Contralateral- K895044 | Braun Fluoro-Tip K945396 | | --- | --- | --- | --- | | Available French Sizes | 5 - 9 French | Curved versions 5.5, 6 & 7 fr Straight versions of the Check-Flo introducer sheaths are available in 4-9 french | 7 - 10 fr | | Available Lengths | curved - 30 - 60 cm straight - 10 - 60 cm | curved - 40 cm straight - 7 - 13 cm | 10 - 32 cm | | Body Stock Design | Braided | non-braided | non-braided, double layer sheath | | Sheath Material | peba | Teflon® | FEP (Teflon®) | | Hub to Body Tensile | 5 fr - 14.5 lbs avg 9 fr - 18.4 lbs avg | 7.2 lbs avg | 7 fr - 14 lbs avg | | Shape Recovery | 5 fr 85% recovery @ 5 sec 86% recovery @ 60 sec 9fr 85% recovery @ 5 sec 88% recovery @ 60 sec | 72% recovery @ 5 sec 77% recovery @ 60 sec | Not applicable | | Sheath Leak Test | No leaks at 100 psi | No leaks at 100 psi | Not performed | | Gasket leak Test | No leaks at 6 psi | No leaks at 6 psi | No leaks at 10 psi | | Kink Resistance | 5 fr - No kinks at 170° 9 fr - Kinked at avg of 107° | Kinked at an avg of 76° | Not performed | | Radiopacity | More visible than Cook | Less visible than Braun | Not compared against Cook | 3 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K960406](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K960406) **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