3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
FDA 510(k) clearance K861985 · decided 1986-12-04
Clearance details
- K-number
- K861985
- Device name
- 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1986-05-22
- Decision date
- 1986-12-04
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MVR
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cottae Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Gem FlowCoupler System (K190499) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
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| GEM Flow COUPLER Device and System (K143589) | Synovis Life Technologies, Inc. | 2015-01-16 |
| GEM Flow COUPLER Device and System (K142309) | Synovis Life Technologies, Inc. | 2014-09-16 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K132727) | Synovis Life Technologies, Inc. | 2013-10-22 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K093310) | Synovis Micro Companies Alliance, Inc. | 2010-02-01 |
| VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (K090679) | Vioptix, Inc. | 2009-04-17 |
| MICROVASCULAR ANASTOMOTIC DEVICE (K040163) | Synovis Micro Companies Alliance, Inc. | 2004-04-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |