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

Midline Catheter

21 CFR 880.5200 / General Hospital
FDA source (opens on fda.gov)

PND is the FDA product code for Midline Catheter, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
PND
Device name
Midline Catheter
FDA definition
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
10

Clearances, product code PND

By decision year
13 clearances under product code PND with a decision year between 2016 and 2025, 2016 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PND by decision year
YearClearances
20163
20173
20182
20191
20211
20222
20251

Applicants with the most clearances

Product code PND
Applicants holding the most 510(k) clearances under product code PND
ApplicantClearances
C.R. Bard Inc4
PFM Medical GmbH2
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)1
Arrow International LLC (subsidiary of Teleflex Incorporated)1
Medcomp (dba Medical Components, Inc.)1
Medical Components, Inc.1
Piper Access, LLC1
Terumo Medical Products (Hangzhou) Co., Ltd.1
Vygon U.S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order