510(k) K022059
- Device
- MICROVASIVE PULMONARY GUIDEWIRE
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K022059
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-13
- Date received
- 2002-06-25
- Regulation
- 878.4800
- Classification name
- Instrument, Manual, Surgical, General Use
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES D MCMAHON
- Address
- One Boston Scientific Pl. Natick, MA US 01760 01760
FDA Registration Numbers#
- 3019696820
- 1222780
- 9617601
- 1423537
- 9614093
- 9614986
- 1000484830
- 8010769
- 3003674698
- 3007515069
- 9021987
- 3034669683
- 3042023934
- 3013756169
- 3039169546
- 9611262
- 3043007473
- 3003637761
- 3013700547
- 3005809810
- 3010287737
- 3036795921
- 2320767
- 3016248634
- 3012656745
- 1055890
- 3010400367
- 3008110533
- 3018940271
- 3010047454
- 2431453
- 1223656
- 1047843
- 3005599545
- 2433012
- 1421101
- 3015895045
- 3021680161
- 9681191
- 1054241
- 2245304
- 1928237
- 3009233038
- 9611278
- 8010733
- 3006378738
- 3010097171
- 3007047889
- 3011301313
- 3011706110
- 8010273
- 3009756327
- 1032347
- 9611502
- 3008729892
- 3004024955
- 3016989300
- 1220477
- 8040179
- 3010047402
- 9611274
- 3010273872
- 1422598
- 8043507
- 3013429557
- 3016080683
- 3006272282
- 3008386507
- 3030149892
- 3009139917
- 3042235752
- 3007597038
- 3003781173
- 3010864832
- 9680271
- 2032677
- 1063481
- 8010300
- 3002807115
Source Documents#
Other 510(k) Records For Product Code MDM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | 2001-12-07 |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | 1994-07-19 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |
Legacy Summary#
summary
FDA Review#
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