510(k) K882479
- Device
- 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP
- Applicant
- MEDTRONIC BLOOD SYSTEMS, INC.
- 510(k) number
- K882479
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-18
- Date received
- 1988-06-16
- 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
- DENNIE E DYER
- Address
- 4633 E. Lapalma Ave. Anaheim CA US 92807 92807
FDA Registration Numbers#
- 3005809810
- 1226015
- 5906
- 9611502
- 3008592544
- 2011171
- 3006516512
- 9611616
- 3011642792
- 2182208
- 3006897899
- 9613079
- 3049552730
- 1649833
- 8010871
- 1417592
- 1649914
- 9611813
- 3004111573
- 3005440795
- 8010877
- 3015895045
- 8010851
- 1055890
- 2529846
- 1000165971
- 3003675041
- 8010099
- 8010697
- 1649139
- 3011111237
- 1416666
- 3004365956
- 1424263
- 8010168
- 3003803182
- 1643817
- 3036795921
- 8040278
- 3042940336
- 8043548
- 9616227
- 1047843
- 1319660
- 1923569
- 3012185136
- 8043496
- 8010273
- 3031231776
- 1724474
- 3007135583
- 3005528784
- 1056350
- 1220477
- 8010257
- 2244478
- 8043895
- 8010386
- 3014334038
- 3004215117
- 1058726
- 8010376
- 1647149
- 8040233
- 2025816
- 3005698350
- 3005941719
- 2030624
- 3012536737
- 2126670
- 3012434811
- 9617604
- 8010370
- 3010531069
- 9680518
- 3010235355
- 1421879
- 3008388245
- 9616088
- 1063481
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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