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FDA 510(k)

SafeSept Blunt Needle

K-Number: K210328 · 2021-03-05

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2021-03-05
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSept Blunt Needle 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 2021-03-05 under 510(k) number K210328. 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 Blunt Needle?

SafeSept Blunt Needle is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K210328.

When did SafeSept Blunt Needle receive FDA 510(k) clearance?

SafeSept Blunt Needle received FDA 510(k) clearance on 2021-03-05, under 510(k) number K210328.

Who is the listed applicant for SafeSept Blunt Needle?

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 Blunt Needle?

The FDA product code for SafeSept Blunt Needle 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)K221707SafeSept® Transseptal Guidewire (SS-140)K181031TSI 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, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K172950TSN 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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