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

Dilator, Vessel, Surgical

21 CFR 870.4475 / Cardiovascular
FDA source (opens on fda.gov)

DWP is the FDA product code for Dilator, Vessel, Surgical, a class II device type, regulated under 21 CFR 870.4475. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DWP
Device name
Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
1

Clearances, product code DWP

By decision year
20 clearances under product code DWP with a decision year between 1979 and 2023, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DWP by decision year
YearClearances
19792
19812
19821
19831
19841
19891
19901
19914
19961
20031
20101
20131
20171
20191
20231

Applicants with the most clearances

Product code DWP
Applicants holding the most 510(k) clearances under product code DWP
ApplicantClearances
American Edwards Laboratories3
Bio-Vascular, Inc.2
Shiley, Inc.2
Abbott Medical1
Baxter Healthcare Corporation1
Cimed Intl., Inc.1
Fehling Surgical Instruments, Inc.1
Fetzer Medical GmbH & Co.KG1
Geister Medizin Technik GmbH1
Geomed Medizin-Technik GmbH & Co. KG1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order