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FDA 510(k)

PERCUTANEOUS INTRODUCER SHEATH SET

K-Number: K771230 · 1977-08-16

ApplicantMedical Disposables Intl., Inc.
Decision Date1977-08-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS INTRODUCER SHEATH SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Disposables Intl., Inc.. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771230. 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 PERCUTANEOUS INTRODUCER SHEATH SET?

PERCUTANEOUS INTRODUCER SHEATH SET is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Medical Disposables Intl., Inc.. The 510(k) number is K771230.

When did PERCUTANEOUS INTRODUCER SHEATH SET receive FDA 510(k) clearance?

PERCUTANEOUS INTRODUCER SHEATH SET received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771230.

Who is the listed applicant for PERCUTANEOUS INTRODUCER SHEATH SET?

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

What is the FDA product code for PERCUTANEOUS INTRODUCER SHEATH SET?

The FDA product code for PERCUTANEOUS INTRODUCER SHEATH SET is DQX.

Related Clinical Trials

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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Other records listing Medical Disposables Intl., 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.

K771231ARTEOIAL LINE KITK770945POUCH, TYVEK-POLYMYLONK770699NEEDLE SET, A-V FISTULAK770552CATHETER, KIDNEY DIALYSIS, HEMO-CATH IIK761078HEMO-CATH I, KIDNEY DIALYSIS CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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