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FDA 510(k)

FLEXIBLE VISUALIZATION CATHETER

K-Number: K862872 · 1986-10-24

ApplicantAmerican Edwards Laboratories
Decision Date1986-10-24
Product CodeFEI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE VISUALIZATION CATHETER 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 1986-10-24 under 510(k) number K862872. The device is classified under product code FEI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE VISUALIZATION CATHETER?

FLEXIBLE VISUALIZATION CATHETER is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is American Edwards Laboratories. The 510(k) number is K862872.

When did FLEXIBLE VISUALIZATION CATHETER receive FDA 510(k) clearance?

FLEXIBLE VISUALIZATION CATHETER received FDA 510(k) clearance on 1986-10-24, under 510(k) number K862872.

Who is the listed applicant for FLEXIBLE VISUALIZATION CATHETER?

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 FLEXIBLE VISUALIZATION CATHETER?

The FDA product code for FLEXIBLE VISUALIZATION CATHETER is FEI.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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Related Devices (Code: FEI)

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.

K873795M-LENS (THIRTY DEGREE ENDOSCOPE)Opto Vision, Inc.

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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