← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K961745

# BRAUN PERCUTANEOUS INTRODUCER SET (K961745)

_B.Braun Medical, Inc. · DYB · Sep 17, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K961745

## Device Facts

- **Applicant:** B.Braun Medical, Inc.
- **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md)
- **Decision Date:** Sep 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for 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.

## Regulatory 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](/device/K810460.md))
- Angeion Hemostasis Introducer Set ([K894446](/device/K894446.md))
- Venous Introducer ([K894446](/device/K894446.md)/[K884494](/device/K884494.md))
- 888 Percutaneous Catheter Introducer ([K771982](/device/K771982.md)/[K770561](/device/K770561.md))
- PCI Kit ([K780126](/device/K780126.md))
- Arterial/Venous Percutaneous Catheter Introducer ([K850820](/device/K850820.md))
- Valveless/Portless Sheath Introducer ([K932733](/device/K932733.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/).

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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 (610)691-5400

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  |

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K961745](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K961745)

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