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FDA 510(k)

FORGARTY BALLOON CALIBRATOR

K-Number: K830734 · 1983-04-12

ApplicantAmerican Edwards Laboratories
Decision Date1983-04-12
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORGARTY BALLOON CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830734. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORGARTY BALLOON CALIBRATOR?

FORGARTY BALLOON CALIBRATOR is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is American Edwards Laboratories. The 510(k) number is K830734.

When did FORGARTY BALLOON CALIBRATOR receive FDA 510(k) clearance?

FORGARTY BALLOON CALIBRATOR received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830734.

Who is the listed applicant for FORGARTY BALLOON CALIBRATOR?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORGARTY BALLOON CALIBRATOR?

The FDA product code for FORGARTY BALLOON CALIBRATOR is DQO.

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Related Devices (Code: DQO)

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K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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