BRAUN HEMOSTASIS INTRODUCERS
Device Facts
| Record ID | K955820 |
|---|---|
| Device Name | BRAUN HEMOSTASIS INTRODUCERS |
| Applicant | B.Braun Medical, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Mar 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Intended 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.
Indications for Use
Indicated for percutaneous introduction of catheters into the vasculature in patients requiring vascular access.
Regulatory Classification
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)
- Burron Cardiovascular Angestat (K931743)
- ANGETEAR Tear-away Introducer Kits (K871153)
- Fluoro-tip Hemostasis Introducer Set (K930057)
- Fluoro-tip Hemostasis Introducer Set (K945396)
Related Devices
- K112407 — SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS · Smiths Medical MD, Inc. · Feb 9, 2012
- K222184 — Introducer Sheath Kits · Beijing Demax Medical Technology Co.,Ltd · Feb 21, 2023
- K960917 — PERCUGLIDE · Scientific Device Manufacturer, LLC · Jul 2, 1996
- K963388 — VESSEL DILATOR · Maxxim Medical · Mar 11, 1997
- K983023 — MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM · Cordis Corp. · Oct 1, 1998
Submission Summary (Full Text)
{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 |
