510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PTDClass II

Subcutaneous Implanted Apheresis Port

21 CFR 880.5965 / General Hospital
FDA source (opens on fda.gov)

PTD is the FDA product code for Subcutaneous Implanted Apheresis Port, a class II device type, regulated under 21 CFR 880.5965. FDA's definition for this code reads: "A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PTD
Device name
Subcutaneous Implanted Apheresis Port
FDA definition
A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PTD

By decision year
3 clearances under product code PTD with a decision year between 2017 and 2020, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTD by decision year
YearClearances
20171
20191
20201

Applicants with the most clearances

Product code PTD
Applicants holding the most 510(k) clearances under product code PTD
ApplicantClearances
C.R. Bard Inc2
Norfolk Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code