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FDA 510(k)

CAAS II LVA BIPLANE OPTION

K-Number: K982203 · 1998-07-14

ApplicantPie Medical Equipment B.V.
Decision Date1998-07-14
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS II LVA BIPLANE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K982203. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAAS II LVA BIPLANE OPTION?

CAAS II LVA BIPLANE OPTION is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K982203.

When did CAAS II LVA BIPLANE OPTION receive FDA 510(k) clearance?

CAAS II LVA BIPLANE OPTION received FDA 510(k) clearance on 1998-07-14, under 510(k) number K982203.

Who is the listed applicant for CAAS II LVA BIPLANE OPTION?

The FDA 510(k) record lists Pie Medical Equipment B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAAS II LVA BIPLANE OPTION?

The FDA product code for CAAS II LVA BIPLANE OPTION is IZI.

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Other records listing Pie Medical Equipment B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945540CAAS IIK915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250K912819SC1150 CW/PDK911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBEK9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

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Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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