BRAUN PERCUTANEOUS INTRODUCER SET

K961745 · B.Braun Medical, Inc. · DYB · Sep 17, 1996 · Cardiovascular

Device Facts

• Record ID: K961745
• Device Name: BRAUN PERCUTANEOUS INTRODUCER SET
• Applicant: B.Braun Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

Device Story

Braun Percutaneous Introducer Kits consist of introducer sheath, dilator, guidewire, and introducer needle. Used by clinicians to facilitate percutaneous vascular access for subsequent device placement. Sheath/dilator assembly inserted into vasculature; provides conduit for catheter or lead delivery. Benefits include simplified vascular access and reduced trauma during device introduction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Teflon FEP or HDPE sheath, HDPE dilator. Dimensions: 3-9 Fr, 7-24 cm length. Mechanical device; no energy source or software. Non-active.

Indications for Use

Indicated for percutaneous introduction of medical devices 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

• Burron Percutaneous Introducer Set (K810460)
• Angeion Hemostasis Introducer Set (K894446)
• Venous Introducer (K894446/K884494)
• 888 Percutaneous Catheter Introducer (K771982/K770561)
• PCI Kit (K780126)
• Arterial/Venous Percutaneous Catheter Introducer (K850820)
• Valveless/Portless Sheath Introducer (K932733)

Submission Summary (Full Text)

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K961745
SEP 17 1996

# II. SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address: B. Braun Medical Inc., 824 Twelfth Avenue
Bethlehem, PA 18018 [phone]

Contact: Mark Alsberge, Regulatory Affairs Manager
Date Prepared: 05/01/96
Common or Usual Name: Braun Percutaneous Introducer Set
Device Classification Name: Catheter Introducers & vessel dilators

## Substantial Equivalence:

K810460
K894446
K894343 and/or K884494
K771982 and/or K770561
K780126
K850820
K932733

Burron Percutaneous Introducer Set
Angeion Hemostasis Introducer Set
Venous Introducer
"888" Percutaneous Catheter Introducer
PCI Kit
Arterial/Venous Percutaneous Catheter Introducer
Valveless/Portless Sheath Introducer

B. Braun Medical, Inc.
B. Braun Medical, Inc.
Daig
USCI
Argon
Universal Medical Instrument(UMI)
Cordis

## Device Description:

Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.

## Statement of Intended Use:

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

## Summary/Comparison of Technological Characteristics:

| | Braun PCI | K810460 | K894446 | Daig | USCI | Argon | UMI | Cordis |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Fr sizes | 3 - 9 | 6-8 | 4-15 | 4 - 9 | 4 - 9 | 4 - 9 | 4 - 8 | 6 - 8 |
| Lengths | 7 - 24 cm | not specified in 510(k) | 12 - 24 cm | 8.5 - 12 cm | 8 - 12 cm | unknown | 14 cm | 11 cm |
| Matls | Teflon FEP or HDPE sheath with HDPE dilator | Teflon® FEP sheath & dilator | Teflon® FEP sheath and HDPE dilator | unknown - "proprietary materials" | Teflon | unknown | white teflonsheath with polyethylene dilator | unknown |
| Sideport | no | yes | yes | no | no | no | no | no |
| Gasket | no | no | yes | no | no | no | no | no |
| Use | percutaneous introduction of devices into the vasculature | percutaneous introduction of devices into the vasculature | percutaneous introduction of catheters into the vasculature while minimizing the backflow of blood. | Designed for introduction of electrophysiology and other catheters into the venous system | percutaneous introduction of catheters into the vasculature (either venous or arterial) | percutaneous introduction of balloon catheters, closed end catheters and temporary pacing leads into the vasculature. | percutaneous introduction of catheters into the vasculature (either venous or arterial) | percutaneous introduction of catheters into the vasculature |