KSEA MODEL 383320 20 ANGIOMAT

K960486 · Karl Storz Endoscopy · DQI · Oct 25, 1996 · Cardiovascular

Device Facts

• Record ID: K960486
• Device Name: KSEA MODEL 383320 20 ANGIOMAT
• Applicant: Karl Storz Endoscopy
• Product Code: DQI · Cardiovascular
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The KSEA model 383320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angioscope manual for specific indications and contraindications for use.

Device Story

Microprocessor-based infusion pump; provides clear field of view during peripheral vascular endoscopy. Features user-adjustable flow rates and pressure settings; includes bubble detection, pressure monitoring, volume monitoring, and flow control. Operates in two modes with bolus infusion function. Used by clinicians in percutaneous or intra-operative settings. Output assists visualization during endoscopic procedures; enhances procedural clarity for the physician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-based infusion pump; includes bubble detection, pressure monitoring, volume monitoring, and flow control sensors. User-adjustable flow and pressure settings.

Indications for Use

Indicated for providing a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system.

Submission Summary (Full Text)

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Karl Storz

Endoscopy-America, Inc.

600 Corporate Pointe

Culver City, California 90230-7600

Phone [phone]

Toll Free 800 421 0837

Fax [phone]

K9104840

OCT 25 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

Applicant: Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

Contact: Betty M. Johnson
Manager, Regulatory Affairs

Device Identification: Common Name
Infusion Pump

Trade Name
KSEA Model 383320 20 Angiomat

Indication: The KSEA model 383320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angioscope manual for specific indications and contraindications for use.

Device Description: The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is a microprocessor-based infusion pump, with user adjustable flow rates and pressure adjustment. The unit incorporates a wide variety of safety features including: bubble detection, pressure monitoring, volume monitoring and flow control. The Angiomat has two operating modes and also incorporates a bolus infusion function.

Substantial Equivalence: The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the KSEA Angiomat and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed: 

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