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FDA 510(k)

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE

K-Number: K980762 · 1998-09-01

ApplicantPall Corp.
Decision Date1998-09-01
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pall Corp.. It received FDA 510(k) clearance on 1998-09-01 under 510(k) number K980762. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE?

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE is a medical device that received FDA 510(k) clearance on 1998-09-01. The listed applicant is Pall Corp.. The 510(k) number is K980762.

When did PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE receive FDA 510(k) clearance?

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE received FDA 510(k) clearance on 1998-09-01, under 510(k) number K980762.

Who is the listed applicant for PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE?

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

What is the FDA product code for PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE?

The FDA product code for PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE is DTM.

Related Clinical Trials

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.

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Other records listing Pall Corp. 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.

K022167PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEMK993379PALL SUPOR AEF FILTER

Related Devices (Code: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

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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