DPTClass II
Probe, Blood-Flow, Extravascular
21 CFR 870.2120 / Cardiovascular
DPT is the FDA product code for Probe, Blood-Flow, Extravascular, a class II device type, regulated under 21 CFR 870.2120. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 24 recalls.
Classification record
- Product code
- DPT
- Device name
- Probe, Blood-Flow, Extravascular
- Regulation
- 21 CFR 870.2120
- 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
- 48
- Ingested recalls
- 24
Clearances, product code DPT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1983 | 1 |
| 1986 | 3 |
| 1988 | 9 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 2001 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code DPT| Applicant | Clearances |
|---|---|
| Moor Instruments Ltd. | 8 |
| Deltex Medical Limited | 3 |
| Hewlett-Packard Co. | 3 |
| Vasamedics, LLC | 3 |
| Aimago SA | 2 |
| Medtronic, Inc. | 2 |
| Spectralmd, Inc. | 2 |
| Acuson Computed Sonography | 1 |
| Advance Medical Device, Inc. | 1 |
| Advanced Technology Laboratories, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Deltex Medical Limited
- DSV Contract Logistics
- ICU Medical Healthcare Manufacturing S.A. de C.V.
- Medistim ASA
- MEDLINE INDUSTRIES, LP (Northpoint Services)
- Medtronic Mexico S. de R.L. de CV
- Medtronic Perfusion Systems
- Midwest Sterilization Corp.
- Moor Instruments Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
