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FDA 510(k)

PERCUTANEOUS INTRODUCERS

K-Number: K903530 · 1990-10-22

ApplicantDavol, Inc.
Decision Date1990-10-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS INTRODUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K903530. 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 PERCUTANEOUS INTRODUCERS?

PERCUTANEOUS INTRODUCERS is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Davol, Inc.. The 510(k) number is K903530.

When did PERCUTANEOUS INTRODUCERS receive FDA 510(k) clearance?

PERCUTANEOUS INTRODUCERS received FDA 510(k) clearance on 1990-10-22, under 510(k) number K903530.

Who is the listed applicant for PERCUTANEOUS INTRODUCERS?

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

What is the FDA product code for PERCUTANEOUS INTRODUCERS?

The FDA product code for PERCUTANEOUS INTRODUCERS is DYB.

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Other records listing Davol, 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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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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