510(k) K790124
- Device
- GRAFT TUNNELER
- Applicant
- NARCO SCIENTIFIC
- 510(k) number
- K790124
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-08
- Date received
- 1979-01-23
- 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
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 9617601
- 9611503
- 2518902
- 1721504
- 3003687489
- 3015398570
- 3005528784
- 1649395
- 1647149
- 3003477135
- 9615005
- 3009763019
- 9614062
- 3035678069
- 2017865
- 8010370
- 3015895045
- 3011175548
- 3008500478
- 3003826419
- 3035708926
- 3003988575
- 1043214
- 3010407203
- 3009051888
- 3010455030
- 9611262
- 3010055973
- 8043496
- 8010254
- 9611616
- 1720929
- 9611502
- 2084346
- 3009340886
- 3003915875
- 3005593675
- 3004111573
- 1000393132
- 2529846
- 1424478
- 1313525
- 9611274
- 1319660
- 3003322138
- 3013938829
- 3010235355
- 3007135583
- 8010422
- 3010687973
- 8010300
- 1223651
- 8010528
- 3015542130
- 3005182241
- 3017540705
- 1220648
- 3003431869
- 1721251
- 3042940336
- 1056553
- 3003597504
- 3004365956
- 3007410669
- 3007648354
- 1421101
- 8010395
- 1123010
- 3010197700
- 8010665
- 1935627
- 3013750125
- 9611610
- 3013288201
- 3014579161
- 3008592544
- 3003803182
- 3023190433
- 2184009
- 9680519
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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