← Product Code [DQI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQI) · K960486 # KSEA MODEL 383320 20 ANGIOMAT (K960486) _Karl Storz Endoscopy · DQI · Oct 25, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQI/K960486 ## Device Facts - **Applicant:** Karl Storz Endoscopy - **Product Code:** [DQI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQI.md) - **Decision Date:** Oct 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1800 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **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. ## 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} K K Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 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 (310) 558-1500 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: ![img-0.jpeg](img-0.jpeg) 000053 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQI/K960486](https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQI/K960486) **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. 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