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FDA 510(k)

ANGIOSCOPE

K-Number: K865017 · 1987-12-15

ApplicantMansfield Scientific, Inc.
Decision Date1987-12-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Mansfield Scientific, Inc.. It received FDA 510(k) clearance on 1987-12-15 under 510(k) number K865017. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOSCOPE?

ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1987-12-15. The listed applicant is Mansfield Scientific, Inc.. The 510(k) number is K865017.

When did ANGIOSCOPE receive FDA 510(k) clearance?

ANGIOSCOPE received FDA 510(k) clearance on 1987-12-15, under 510(k) number K865017.

Who is the listed applicant for ANGIOSCOPE?

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

What is the FDA product code for ANGIOSCOPE?

The FDA product code for ANGIOSCOPE is DQX.

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Other records listing Mansfield Scientific, 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.

K870186ENDOMYOCARDIAL BIOPSY DEVICEK855103CIRIBART GYUDUBG CATGETERK853850EXPLORERK852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODEK851848PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETERK844752TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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