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FDA 510(k)

MODEL 556-01 CRYOEXTRACTOR

K-Number: K790102 · 1979-02-12

ApplicantIntermedics, Inc.
Decision Date1979-02-12
Product CodeHPS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 556-01 CRYOEXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1979-02-12 under 510(k) number K790102. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 556-01 CRYOEXTRACTOR?

MODEL 556-01 CRYOEXTRACTOR is a medical device that received FDA 510(k) clearance on 1979-02-12. The listed applicant is Intermedics, Inc.. The 510(k) number is K790102.

When did MODEL 556-01 CRYOEXTRACTOR receive FDA 510(k) clearance?

MODEL 556-01 CRYOEXTRACTOR received FDA 510(k) clearance on 1979-02-12, under 510(k) number K790102.

Who is the listed applicant for MODEL 556-01 CRYOEXTRACTOR?

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

What is the FDA product code for MODEL 556-01 CRYOEXTRACTOR?

The FDA product code for MODEL 556-01 CRYOEXTRACTOR is HPS.

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Other records listing Intermedics, Inc. 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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Related Devices (Code: HPS)

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.

K202038CryoTreQVitreQ BVK940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.K923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESSpembly Medical , Ltd.K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.K873388KEELER CTU CRYO SYSTEMKeeler Instruments, 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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