HUNTER-SESSIONS VENA-CAVA OCCLUDER
FDA premarket approval P770005 · decided 1977-12-19
Approval details
- PMA number
- P770005
- Trade name
- HUNTER-SESSIONS VENA-CAVA OCCLUDER
- Generic name
- OCCLUDER, BALLOON, VENA-CAVA
- Applicant
- Concept, Inc.
- Date received
- 1977-07-07
- Decision date
- 1977-12-19
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LWT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Clearwater, FL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CONCEPT ENDOSTEAL FIXATION DEVICE (K912640) | Concept, Inc. | 1992-05-01 |
| CONCEPT MICROMILL (K912957) | Concept, Inc. | 1991-10-04 |
| CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (K896648) | Concept, Inc. | 1990-06-05 |
| STAPLE FIXATION SYSTEM (K894929) | Concept, Inc. | 1989-08-30 |
| INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (K892376) | Concept, Inc. | 1989-08-01 |
| PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (K891109) | Concept, Inc. | 1989-05-08 |
| CONCEPT POWER SYSTEM (K881954) | Concept, Inc. | 1988-11-09 |
| CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (K884255) | Concept, Inc. | 1988-11-08 |