510(k) K830471
- Device
- KELLY-WICK TANNELER
- Applicant
- INTL. MEDICAL PROSTHETICS RESEARCH
- 510(k) number
- K830471
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-02-15
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9617601
- 3005528784
- 9610905
- 1063481
- 3003882387
- 8043404
- 9611274
- 1320468
- 2245304
- 1047843
- 1724474
- 1223651
- 9611112
- 9680519
- 2529846
- 9611502
- 3004961578
- 1923569
- 3007207906
- 9610612
- 3009750712
- 1522875
- 2030598
- 3012448339
- 3011137372
- 3003988575
- 8010300
- 1055236
- 3003687489
- 3008998256
- 1319660
- 9610557
- 8010386
- 3015970743
- 9611278
- 3007773213
- 3012507533
- 3003477135
- 9616088
- 3004215117
- 1720747
- 3004365956
- 1054241
- 3005182241
- 3006950086
- 8040233
- 9611610
- 1319639
- 3013846070
- 2011171
- 9616972
- 1421101
- 3015309643
- 2015691
- 3006554912
- 2183319
- 3032747418
- 3008388245
- 3013288201
- 3009340886
- 3010687973
- 8044098
- 9612074
- 3005273623
- 3003696170
- 8010704
- 1417592
- 2518902
- 1056553
- 8010871
- 3011111237
- 1721676
- 1061124
- 9613079
- 3007410669
- 3035678069
- 1056350
- 8010405
- 9611503
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#
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