CATHETER, MEDIASTINAL&PERICARDIAL
FDA 510(k) clearance K771986 · decided 1977-10-28
Clearance details
- K-number
- K771986
- Device name
- CATHETER, MEDIASTINAL&PERICARDIAL
- Applicant
- The Minnesota Back Brace Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-19
- Decision date
- 1977-10-28
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- FHF
- Device class
- 2
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 |
| SUCTION IRRIGATOR (K003443) | Applied Medical | 2001-02-01 |
Recalls involving this device
No recalls on record reference this clearance.