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FDA 510(k)

DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.

K-Number: K872770 · 1987-10-15

ApplicantNova Medical Specialties
Decision Date1987-10-15
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Nova Medical Specialties. It received FDA 510(k) clearance on 1987-10-15 under 510(k) number K872770. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.?

DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Nova Medical Specialties. The 510(k) number is K872770.

When did DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. receive FDA 510(k) clearance?

DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. received FDA 510(k) clearance on 1987-10-15, under 510(k) number K872770.

Who is the listed applicant for DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.?

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

What is the FDA product code for DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.?

The FDA product code for DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. is DYG.

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Other records listing Nova Medical Specialties as applicant

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K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHK853625NOVA ARTERIAL EMBOLECTOMY CATHETERK840009NOVA 12 CARDIAC OUTPUT COMPUTERK841639NOVA BALLOON THERMODILUTION CATH.K841640NOVA BALLOON THERMODILUTION INFUSIONK834037HEPARIN COATED BALLOON THERMODILU

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Related Devices (Code: DYG)

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.

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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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