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FDA 510(k)

EXACTA PERCUTANEOUS INTRODUCER SHEATH

K-Number: K941428 · 1994-07-06

ApplicantOhmeda Medical
Decision Date1994-07-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXACTA PERCUTANEOUS INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K941428. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTA PERCUTANEOUS INTRODUCER SHEATH?

EXACTA PERCUTANEOUS INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Ohmeda Medical. The 510(k) number is K941428.

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

EXACTA PERCUTANEOUS INTRODUCER SHEATH received FDA 510(k) clearance on 1994-07-06, under 510(k) number K941428.

Who is the listed applicant for EXACTA PERCUTANEOUS INTRODUCER SHEATH?

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

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

The FDA product code for EXACTA PERCUTANEOUS INTRODUCER SHEATH is DYB.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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