510(k) K896307
- Device
- INSULATION PAD
- Applicant
- BIO-VASCULAR, INC.
- 510(k) number
- K896307
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-19
- Date received
- 1989-10-31
- 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
- SHERRY KRATTLEY
- Address
- 2670 Patton Rd. St. Paul MN US 55113 55113
FDA Registration Numbers#
- 1066959
- 2184009
- 3010197700
- 2431166
- 2029275
- 3004111573
- 9611274
- 9616972
- 3032747418
- 3011371465
- 2020394
- 1836161
- 8010395
- 9611616
- 9616250
- 3008388245
- 3005687633
- 3012185136
- 3015542130
- 2434839
- 9611827
- 3043543260
- 1416666
- 3008902714
- 9610557
- 1000393132
- 3011642792
- 1056553
- 8040233
- 8010269
- 2242352
- 3003955307
- 1061124
- 8010704
- 8010591
- 3012507533
- 3005809810
- 2529846
- 1055236
- 1721251
- 3007507973
- 3010455030
- 3036795921
- 3042278955
- 1000165971
- 2017865
- 3006554912
- 1423537
- 3000286616
- 2183744
- 3048101437
- 3007773213
- 2025816
- 3014615697
- 3010699884
- 3005726885
- 3010055973
- 1036836
- 2245304
- 3035708926
- 3031231776
- 9614062
- 1424478
- 5906
- 9611814
- 3003915875
- 3008770252
- 2084346
- 3013750125
- 9610621
- 8043895
- 3003322138
- 1921846
- 1063481
- 8010376
- 3007137643
- 1417592
- 3012434811
- 8031015
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 |
| 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 |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | 1989-04-10 |
Legacy Summary#
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
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