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FDA 510(k)

SWAN-GANZ HEPARIN COATED, ETC. CATHETER

K-Number: K811411 · 1981-06-12

ApplicantAmerican Edwards Laboratories
Decision Date1981-06-12
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ HEPARIN COATED, ETC. 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 1981-06-12 under 510(k) number K811411. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN-GANZ HEPARIN COATED, ETC. CATHETER?

SWAN-GANZ HEPARIN COATED, ETC. CATHETER is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is American Edwards Laboratories. The 510(k) number is K811411.

When did SWAN-GANZ HEPARIN COATED, ETC. CATHETER receive FDA 510(k) clearance?

SWAN-GANZ HEPARIN COATED, ETC. CATHETER received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811411.

Who is the listed applicant for SWAN-GANZ HEPARIN COATED, ETC. 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 SWAN-GANZ HEPARIN COATED, ETC. CATHETER?

The FDA product code for SWAN-GANZ HEPARIN COATED, ETC. CATHETER is KRB.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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