510(k) K882981
- Device
- PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
- Applicant
- PIONEERING TECHNOLOGIES, INC.
- 510(k) number
- K882981
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-27
- Date received
- 1988-07-15
- 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#
- Contact
- WRIGHT,PHD
- Address
- 143 Union Blvd., Suite 900 Lakewood CO US 80228 80228
FDA Registration Numbers#
- 1123137
- 2245304
- 3004215117
- 1063481
- 1060680
- 3007334784
- 3009703496
- 9612773
- 3016408131
- 8010099
- 3010041511
- 1923569
- 3010687973
- 1066959
- 8010269
- 3015173212
- 3010235355
- 2030624
- 3009959868
- 1724474
- 3033589330
- 1313525
- 2183319
- 3010455030
- 1723241
- 1417485
- 8010704
- 9611273
- 3007207906
- 8043895
- 2030598
- 3008388245
- 1649395
- 9680515
- 9611281
- 9616538
- 8010405
- 8010155
- 2529846
- 3003915875
- 1720929
- 9611617
- 3011642792
- 3011636272
- 9616250
- 1519227
- 3019455
- 3014201171
- 3007137643
- 1417592
- 2183787
- 9611278
- 5906
- 9616972
- 8043769
- 9611502
- 3003988575
- 8043496
- 1721504
- 2183570
- 9610621
- 3006950086
- 1412854
- 1223651
- 1932180
- 2184009
- 3005809810
- 8010273
- 3010407203
- 2248180
- 1522875
- 3008902714
- 3009051888
- 1643817
- 8010168
- 3004608878
- 3022862651
- 3000286616
- 1935627
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 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, 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