ZEBRA UROLOGICAL GUIDEWIRE
FDA 510(k) clearance K942205 · decided 1994-07-07
Clearance details
- K-number
- K942205
- Device name
- ZEBRA UROLOGICAL GUIDEWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1994-05-05
- Decision date
- 1994-07-07
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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| GUARDIAN URETHRAL SHEATH (K141252) | Solace Therapeutics | 2014-06-09 |
| GUARDIAN URETHRAL SHEATH (K131803) | Solace Therapeutics | 2013-08-20 |
| VARI-PASS VARIABLE LENGTH ACCESS SHEATH (K123170) | Olympus Surgical Technologies America | 2013-02-04 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| CYSTOGLIDE INTRODUCER SHEATH (K052298) | Percutaneous Systems, Incorporated | 2006-12-12 |
Recalls involving this device
No recalls on record reference this clearance.