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FDA 510(k)

SimplGuide

K-Number: K261242 · 2026-06-25

ApplicantPendracare
Decision Date2026-06-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SimplGuide is the device name listed in this FDA 510(k) record. The listed applicant is Pendracare. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K261242. 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 SimplGuide?

SimplGuide is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Pendracare. The 510(k) number is K261242.

When did SimplGuide receive FDA 510(k) clearance?

SimplGuide received FDA 510(k) clearance on 2026-06-25, under 510(k) number K261242.

Who is the listed applicant for SimplGuide?

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

What is the FDA product code for SimplGuide?

The FDA product code for SimplGuide is DYB.

Other records listing Pendracare 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.

K250972Primum Hydrophilic Guiding Catheter

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, LLCK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLCK254248Introducer Sheath SetCardiocycle Medical(Suzhou) 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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