CHURCHILL-H EXTENSION TUBE
FDA 510(k) clearance K854629 · decided 1985-12-10
Clearance details
- K-number
- K854629
- Device name
- CHURCHILL-H EXTENSION TUBE
- Applicant
- Churchill Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-18
- Decision date
- 1985-12-10
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FPK
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Langhorne, PA, 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 |
|---|
| MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (K131517) | Medrad, Inc. / Bayer Medical Care, Inc. | 2013-08-02 |
| DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114) | Coeur, Inc. | 2007-02-09 |
| LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 (K063239) | Hospira, Inc. | 2006-12-11 |
| MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431) | Medtronic Minimed | 2005-11-29 |
| EMPOWER TRANSFER SET, (CAT. NO. 7725) (K041178) | E-Z-Em, Inc. | 2004-07-16 |
| MEDRAD SWABBABLE VALVE TRANSFER SET (K031808) | Medrad, Inc. | 2003-07-11 |
| MEDRAD TRANSFER SET (K022431) | Medrad, Inc. | 2002-09-05 |
| POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208) | Medtronic Minimed | 1997-02-26 |
| SILCLEAR TUBING (MODIFICATION) (K953864) | Degania Silicone , Ltd. | 1995-11-06 |
| SYSMEX SF-3000 (K950508) | Sysmex Corp. | 1995-11-03 |
| EXTENSION SET/I.V. SET (K952243) | Coast Medical, Inc. | 1995-07-26 |
| 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP (K952663) | Distronic Sterile Products, Inc. | 1995-07-14 |
Recalls involving this device
No recalls on record reference this clearance.