DILATOR, VESSEL & INTRODUCER, SHEATH
FDA 510(k) clearance K780126 · decided 1978-03-02
Clearance details
- K-number
- K780126
- Device name
- DILATOR, VESSEL & INTRODUCER, SHEATH
- Applicant
- Argon Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-24
- Decision date
- 1978-03-02
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular recall (Z-2705-2026) | Argon Medical Devices, Inc | 2026-07-10 |
| ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast recall (Z-1029-2016) | Argon Medical Devices, Inc | 2016-03-01 |
| Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, recall (Z-0764-2010) | Argon Medical Devices, Inc | 2010-02-02 |