510(k) K882367
- Device
- METATECH MICROCLIP APPLICATOR
- Applicant
- METATECH CORP.
- 510(k) number
- K882367
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-25
- Date received
- 1988-06-08
- 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
- ANTHONY J CIARICO
- Address
- 420 Northgate Pkwy. Wheeling IL US 60090 60090
FDA Registration Numbers#
- 3016408131
- 3022862651
- 3007648354
- 3013497507
- 8043404
- 8044098
- 1649395
- 3003803182
- 9615005
- 3035678069
- 1720747
- 3003418325
- 3012226300
- 1720929
- 8010298
- 3011111237
- 9616250
- 3009763019
- 3005440795
- 8010300
- 8010591
- 3015542130
- 3008592544
- 8040278
- 3023190433
- 1060680
- 8010877
- 1723241
- 9680519
- 8010155
- 3036795921
- 1417485
- 1066959
- 3011175548
- 3012267976
- 9610621
- 9614093
- 2249529
- 2522007
- 3043543260
- 3004111573
- 3000286616
- 1058726
- 3033589330
- 8010273
- 2133928
- 2242352
- 3004608878
- 1640201
- 3008902714
- 1625519
- 2640138
- 3010055973
- 8010851
- 2027111
- 1043214
- 1522875
- 3010687973
- 3003675041
- 3006897899
- 1416666
- 1319660
- 3005593675
- 3003644849
- 2020394
- 3013288201
- 3012185136
- 9616088
- 2011171
- 2529846
- 3005182241
- 1422634
- 1421879
- 1424478
- 1223651
- 9710524
- 3016096142
- 3015924373
- 1220477
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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