← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K955820 # BRAUN HEMOSTASIS INTRODUCERS (K955820) _B.Braun Medical, Inc. · DYB · Mar 25, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K955820 ## Device Facts - **Applicant:** B.Braun Medical, Inc. - **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md) - **Decision Date:** Mar 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. ## Device Story Device consists of 16 and 18 French catheter introducers and vessel dilators; includes silicone gasket to prevent blood backflow. Used by clinicians for percutaneous vascular access. Introducer sheath (FEP with BaSO4) and dilator (high-density polyethylene with bismuth subcarbonate) facilitate catheter placement. Device functions as a mechanical conduit for vascular procedures. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Sheath: FEP with BaSO4. Dilator: High-density polyethylene with bismuth subcarbonate. Gasket: Silicone. Sizes: 16 and 18 French. Lengths: 10-40 cm. Packaging: Tyvek/Polymylar pouch. Sterilization: Not specified. ## Regulatory Identification A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. ## Predicate Devices - Angeion Hemostasis Valve Introducer Kit ([K894446](/device/K894446.md)) - Burron Cardiovascular Angestat ([K931743](/device/K931743.md)) - ANGETEAR Tear-away Introducer Kits ([K871153](/device/K871153.md)) - Fluoro-tip Hemostasis Introducer Set ([K930057](/device/K930057.md)) - Fluoro-tip Hemostasis Introducer Set ([K945396](/device/K945396.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} 3 90 # 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: December 19, 1995 Common or Usual Name: Catheter introducer and Vessel dilator for percutaneous catheterization Device Classification Name: Introducer: 21 CFR Reference- 870.1340, Class II Panel- 74 DYB Dilator: 21 CFR Reference- 870.1310, Class II, Panel- 74 DRE Substantial Equivalence: | 510(k) # | Product | Manufacturer | | --- | --- | --- | | K894446 | Angeion Hemostasis Valve Introducer Kit | B. Braun Cardiovascular - MN | | K931743 | Burron Cardiovascular Angestat | B. Braun Cardiovascular - MN | | K871153 | ANGETEAR Tear-away Introducer Kits | B. Braun Cardiovascular - MN | | K930057 | Fluoro-tip Hemostasis Introducer Set | B. Braun Cardiovascular - MN | | K945396 | Fluoro-tip Hemostasis Introducer Set | B. Braun Cardiovascular - MN | Device Description: 16 & 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm. Statement of Intended Use: For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. Summary/Comparison of Technological Characteristics: | Characteristic | Braun Hemostasis Introducers | K894446 Hemostasis Introducer | K931743 Angestat | K871153 ANGETEAR | | --- | --- | --- | --- | --- | | A) Labeling/Pkg | | | | | | Labels & IFUs | See Attachment B | All Braun Hemostasis Introducer Label formats are identical | All Braun Hemostasis Introducer Label formats are identical | same information provided on pouch and box labels as on hemostasis labels | | Expiration Dating | 2 years | 2 years | 2 years | 4 years | | Pyrogen Free | Yes | Yes | Yes | Yes | | Packaging | Tyvek/Polymylar pouch | Tyvek/Polymylar pouch | Tyvek/Polymylar pouch | Tray w/ tyvek lid w/in a tyvek/polymylar pouch | | B) Intended Use | percutaneous introduction of catheters into the vasculature while minimizing the backflow of blood | percutaneous introduction of catheters into the vasculature while minimizing the backflow of blood | percutaneous introduction of catheters into the vasculature while minimizing the backflow of blood | percutaneous introduction of catheters into the vasculature | | C) Physical Char. | | | | | | Available french sizes | 4-18 french | 5-14 french | 4-15 french | 4-16 french | | Lengths | 10-40 cm | 12-24 cm | 15-32 cm | 16-30 cm | | gasket material | silicone | Natural rubber | silicone | none | | sheath material | FEP with BaSO4 | FEP teflon with BaSO4 | FEP with BaSO4 | polyethylene with bismuth subcarbonate | | dilator material | high density polyethylene with bismuth subcarbonate | polyethylene with bismuth subcarbonate | polyethylene with bismuth subcarbonate | FEP with BaSO4, or polyethylene with bismuth subcarbonate | | D) Anatomical Sites | vasculature | vasculature | vasculature | vasculature | --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K955820](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K955820) **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