NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
FDA 510(k) clearance K034025 · decided 2004-03-26
Clearance details
- K-number
- K034025
- Device name
- NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
- Applicant
- Nmt Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-29
- Decision date
- 2004-03-26
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boston, MA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STARFLEX SEPTAL OCCLUSION SYSTEM (P000049/S016) | Nmt Medical, Inc. | 2009-03-05 |
| CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD (P000049/S019) | Nmt Medical, Inc. | 2008-01-17 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S015) | Nmt Medical, Inc. | 2004-09-13 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S014) | Nmt Medical, Inc. | 2004-05-21 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM (P000049/S013) | Nmt Medical, Inc. | 2004-05-14 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S012) | Nmt Medical, Inc. | 2004-05-10 |
| CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD (P000049/S011) | Nmt Medical, Inc. | 2004-03-24 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S009) | Nmt Medical, Inc. | 2003-07-03 |