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FDA 510(k)

Stiletto Extended Dwell Catheter

K-Number: K210047 · 2021-08-27

ApplicantPiper Access, LLC
Decision Date2021-08-27
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stiletto Extended Dwell Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210047. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stiletto Extended Dwell Catheter?

Stiletto Extended Dwell Catheter is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Piper Access, LLC. The 510(k) number is K210047.

When did Stiletto Extended Dwell Catheter receive FDA 510(k) clearance?

Stiletto Extended Dwell Catheter received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210047.

Who is the listed applicant for Stiletto Extended Dwell Catheter?

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

What is the FDA product code for Stiletto Extended Dwell Catheter?

The FDA product code for Stiletto Extended Dwell Catheter is PND.

Other records listing Piper Access, LLC 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.

K191976Piper GO-IO Intraosseous Infusion SystemK1819045 FR Dual Lumen Piper PICC

Related Devices (Code: PND)

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.

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena(TM) Midline CatheterC.R. Bard, Inc.K192802primeMidline CathetersPfm Medical, Inc.K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USAK173114primeMidline CathetersPfm Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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