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FDA 510(k)

PERCUTANEOUS SHEATH INTRODUCER TRAYS

K-Number: K833574 · 1984-01-11

ApplicantIntermed, Inc.
Decision Date1984-01-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS SHEATH INTRODUCER TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1984-01-11 under 510(k) number K833574. 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 SHEATH INTRODUCER TRAYS?

PERCUTANEOUS SHEATH INTRODUCER TRAYS is a medical device that received FDA 510(k) clearance on 1984-01-11. The listed applicant is Intermed, Inc.. The 510(k) number is K833574.

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

PERCUTANEOUS SHEATH INTRODUCER TRAYS received FDA 510(k) clearance on 1984-01-11, under 510(k) number K833574.

Who is the listed applicant for PERCUTANEOUS SHEATH INTRODUCER TRAYS?

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

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

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

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Other records listing Intermed, 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.

K900857NON STERILE PARENTERAL SUPPLY KITK842166INTERMED, INS STERILE WATER/SALINEK833126DRESSING CHANGE TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833139ACUTE HEMODIALYSIS TRAYSK833059SUCTION CATHETER TRAYS

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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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