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FDA 510(k)

SafeSept® Transseptal Guidewire (SS-140)

K-Number: K221707 · 2022-09-14

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2022-09-14
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSept® Transseptal Guidewire (SS-140) is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K221707. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeSept® Transseptal Guidewire (SS-140)?

SafeSept® Transseptal Guidewire (SS-140) is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K221707.

When did SafeSept® Transseptal Guidewire (SS-140) receive FDA 510(k) clearance?

SafeSept® Transseptal Guidewire (SS-140) received FDA 510(k) clearance on 2022-09-14, under 510(k) number K221707.

Who is the listed applicant for SafeSept® Transseptal Guidewire (SS-140)?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSept® Transseptal Guidewire (SS-140)?

The FDA product code for SafeSept® Transseptal Guidewire (SS-140) is DRC.

Other records listing Pressure Products Medical Device Manufacturing, 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.

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K210328SafeSept Blunt NeedleK181031TSI Transseptal IntroducerK172950TSN Transseptal NeedleK172934Needle Free Transseptal Cannula

View all 9 devices →

Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLCK172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, 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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