510(k) K163524
- Device
- Vessel Dilator
- Applicant
- Fetzer Medical GmbH & Co. KG
- 510(k) number
- K163524
- Product code
- DWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-29
- Date received
- 2016-12-15
- Regulation
- 870.4475
- Classification name
- Dilator, Vessel, Surgical
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Harald Jung
- Address
- Unter Buchsteig 5 Tuttlingen DE 78532 78532
FDA Registration Numbers#
- 2183620
- 1055236
- 1416980
- 1718850
- 9710524
- 8010372
- 3005809810
- 3015451162
- 3004215117
- 3007507973
- 3011137372
- 1421879
- 1056350
- 1417592
- 3007055279
- 1836161
- 3010041511
- 2020394
- 1923569
- 3010687973
- 8040233
- 1424478
- 2916714
- 9680515
- 3008770252
- 1043214
- 9615005
- 8010303
- 8010168
- 3007648354
- 3004608878
- 1724474
- 1421101
- 3012995405
- 1720747
- 1054241
- 2025773
- 3003418325
- 1219659
- 3008864603
- 3005528784
- 2183744
- 8010697
- 3009513193
- 2126670
Source Documents#
Other 510(k) Records For Product Code DWP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023-04-20 |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | 2019-09-03 |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | 2013-04-24 |
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | 2010-08-31 |
| K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | Geister Medizin Technik GmbH | 2003-07-12 |
| K960312 | RDI CARDIAC INSULATION PAD | R D Intl. | 1996-04-19 |
| K912548 | LEMAITRE-BOOKWALTER VESSEL DEVICES | Vascutech, Inc. | 1991-09-18 |
| K911475 | LAPAROSCOPIC VESSEL ARTICULATOR | United States Endoscopy Group, Inc. | 1991-07-02 |
| K910682 | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | 1991-05-08 |
| K905159 | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | 1991-02-07 |
| K902143 | FOGARTY VESSEL CALIBRATOR | Baxter Healthcare Corp | 1990-10-16 |
| K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | Pioneering Technologies, Inc. | 1989-10-12 |
| K833676 | SURGICAL VESSEL DILATORS-CATHERIZA- | Cimed Intl., Inc. | 1984-03-19 |
| K832595 | VESSEL DILATOR | Abbott Laboratories | 1983-08-31 |
| K822687 | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | 1982-10-04 |
Legacy Summary#
summary
FDA Review#
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