HEART CATH TRAY
FDA 510(k) clearance K912052 · decided 1991-08-20
Clearance details
- K-number
- K912052
- Device name
- HEART CATH TRAY
- Applicant
- Medical Device Inspection Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-09
- Decision date
- 1991-08-20
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FSM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Great Neck, NY, 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 |
|---|---|---|
| INSTRUMENT TRAY LINER (K971217) | General Hospital Supply Corp. | 1997-05-06 |
| SINGLE USE INSTRUMENT TRAY (K962328) | Medcare Medical Group, Inc. | 1996-08-09 |
| SURGICAL INSTRUMENT TRAY (K944025) | Riley Medical, Inc. | 1994-11-22 |
| ARTHROSCOPY TRAY (K912106) | Medical Device Inspection Co., Inc. | 1991-08-29 |
| OPEN HEART TRAY (K912053) | Medical Device Inspection Co., Inc. | 1991-08-26 |
| MAJOR BASIN TRAY (K912104) | Medical Device Inspection Co., Inc. | 1991-08-09 |
| SPLINTER TWEEZERS (K910570) | Solan Scissors Sales | 1991-05-31 |
| REDDICK TROCAR AND CANNULA (K911601) | Ideal Medical, Inc. | 1991-05-21 |
| KEY COMFORT GRIPS (K910328) | Key Surgical, Inc. | 1991-03-06 |
| RICHARD-ALLAN CLAMP COVERS (K905682) | Richard-Allan Medical | 1991-02-19 |
| HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) (K900376) | Pmt Corp. | 1990-04-10 |
| CUSTOM TRAYS, KITS (K894610) | L H M Ent., Inc. | 1990-03-15 |
Recalls involving this device
No recalls on record reference this clearance.