TRACHESTOMY & NASAL SUCTIONING KIT #-
FDA 510(k) clearance K830711 · decided 1983-05-02
Clearance details
- K-number
- K830711
- Device name
- TRACHESTOMY & NASAL SUCTIONING KIT #-
- Applicant
- Intertex Medical
- Decision
- Substantially Equivalent
- Date received
- 1983-03-07
- Decision date
- 1983-05-02
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GBZ
- Device class
- 1
- Regulation number
- 878.4200
- 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 |
|---|---|---|
| PRE-VIEW CHOLANGIOGRAPHY CLAMP (K973621) | Nashville Surgical Instruments | 1997-12-17 |
| FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (K944790) | Applied Medical Resources | 1994-11-29 |
| ENDOPATH (K942450) | Ethicon Endo-Surgery, Inc. | 1994-08-05 |
| MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (K932228) | Boston Scientific Corp | 1993-08-10 |
| TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (K926217) | Terumo Medical Corp. | 1993-07-13 |
| ANGIOLAPCATH CHOLANGIOGRAPHY KIT (K926143) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-07-07 |
| STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (K924212) | Stryker Corp. | 1993-07-07 |
| CLARUS CHOLANGIOGRAM CATHETER KIT (K925742) | Clarus Medical Systems, Inc. | 1993-06-01 |
| OPERATIVE CHOLANGIOGRAM CATHETER (K924981) | Taut, Inc. | 1993-04-06 |
| CHOLANGIOGRAPHY CLAMP (K924480) | Applied Medical Resources | 1993-03-03 |
| CHOLANGIOGRAPHY CATHETER (K924128) | Applied Medical Resources | 1993-02-10 |
| CHOLANGIOLAPCATH(TM) (K921091) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-06 |
Recalls involving this device
No recalls on record reference this clearance.