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FDA 510(k)

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT

K-Number: K884159 · 1989-02-22

ApplicantMallinckroot, Inc.
Decision Date1989-02-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckroot, Inc.. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K884159. 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 SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT?

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Mallinckroot, Inc.. The 510(k) number is K884159.

When did SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT receive FDA 510(k) clearance?

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT received FDA 510(k) clearance on 1989-02-22, under 510(k) number K884159.

Who is the listed applicant for SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT?

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

What is the FDA product code for SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT?

The FDA product code for SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT is DYB.

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Other records listing Mallinckroot, 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.

K983830COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETERK894445MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDEK885348A-V(TM) SOFTOUCH UHF CARDIAC PIGTAILK885216ATTACHABLE LANZ (TENTATIVE)K884481CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICEK882130FOLEY-TEMP(TM)

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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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