510(k) K850394
- Device
- LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
- Applicant
- VASCUTECH, INC.
- 510(k) number
- K850394
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-24
- Date received
- 1985-02-01
- Regulation
- 870.4500
- Classification name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL J MANELLI
- Address
- 1120 Vermont Ave. NW Suite 1000 Washington DC US 20005 20005
FDA Registration Numbers#
- 1066959
- 9616250
- 3015225571
- 5906
- 1625519
- 2522007
- 9611503
- 3013846070
- 3008902714
- 1226015
- 1220477
- 1649833
- 1417485
- 3004111573
- 1220648
- 1416666
- 2028523
- 3003322138
- 3012448339
- 1724474
- 1421879
- 1450662
- 3000286616
- 3014201171
- 1649139
- 3005809810
- 8010254
- 8043404
- 9611278
- 3012226300
- 2030624
- 3010055973
- 9610621
- 9610612
- 3010531069
- 1721251
- 1519227
- 9612086
- 3003244954
- 3003882387
- 2242352
- 9616246
- 3033589330
- 1424263
- 1928237
- 3015173212
- 1058726
- 3003826419
- 1720929
- 3003696170
- 1036836
- 8010372
- 9611616
- 2134285
- 3016408131
- 3005941719
- 1721504
- 3011137372
- 3009703496
- 3007135583
- 2126670
- 2020394
- 3011642792
- 8010528
- 3007334784
- 3015451162
- 8010273
- 9612074
- 1720747
- 8010871
- 9610905
- 1421101
- 9611502
- 3007207906
- 1450428
- 3008592544
- 3007648354
- 3019455
- 3023190433
- 8010269
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | 2002-10-09 |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997-01-30 |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-19 |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | 1996-04-15 |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-09 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1994-01-10 |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1989-09-13 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | 1989-07-14 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | 1989-04-13 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases