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FDA 510(k)

PROBE & CATHETER

K-Number: K771663 · 1977-09-20

ApplicantEdwards Laboratories
Decision Date1977-09-20
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROBE & CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1977-09-20 under 510(k) number K771663. 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 PROBE & CATHETER?

PROBE & CATHETER is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is Edwards Laboratories. The 510(k) number is K771663.

When did PROBE & CATHETER receive FDA 510(k) clearance?

PROBE & CATHETER received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771663.

Who is the listed applicant for PROBE & CATHETER?

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

What is the FDA product code for PROBE & CATHETER?

The FDA product code for PROBE & CATHETER is KRB.

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Other records listing 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.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESIS

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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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