VESSEL OCCLUDER
FDA 510(k) clearance K800074 · decided 1980-01-28
Clearance details
- K-number
- K800074
- Device name
- VESSEL OCCLUDER
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-01-14
- Decision date
- 1980-01-28
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- GDJ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Standard Clamp (K153358) | Standard Bariatrics | 2016-05-02 |
| THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE (K930315) | Thomasville Medical Assoc. | 1994-02-04 |
| MAR-MED LIVER STRAP (K924223) | Mar-Med Co. | 1993-03-18 |
| GENERAL SURGERY CLAMP AND NEEDLE HOLDER (K922659) | Miltex Instrument Co. | 1992-07-21 |
| GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (K914913) | Ideal Medical, Inc. | 1991-12-31 |
| GS-7100 CHOLANGIOGRAM CLAMP, 5MM (K900956) | Solos Endoscopy, Inc. | 1990-04-18 |
| MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (K901107) | United States Surgical, A Division of Tyco Healthc | 1990-04-09 |
| VESSEL OCCLUDER (K895726) | Applied Medical Technologies | 1989-10-24 |
| SILICONE INSTRUMENT SHODS (K895591) | Key Surgical, Inc. | 1989-10-20 |
| SURGICAL DUCT CLAMP (VINE) (K882169) | Henley Intl. | 1988-06-17 |
| STUART LEE CLIP (K881741) | Stuart-Lee, Inc. | 1988-06-03 |
| UTILITY CLAMP (K881084) | Med-Dex Intl. | 1988-03-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |