CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
FDA 510(k) clearance K895775 · decided 1990-04-23
Clearance details
- K-number
- K895775
- Device name
- CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1989-09-27
- Decision date
- 1990-04-23
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- KTB
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| Macroduct Advanced Model 3710 (K180627) | Elitechgroup, Inc. | 2018-07-27 |
| RH-950 (K033192) | Iomed, Inc. | 2003-12-22 |
| NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (K031551) | Vyteris, Inc. | 2003-08-20 |
| RH-900 (K031115) | Iomed, Inc. | 2003-07-10 |
| NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (K010031) | Wescor, Inc. | 2001-03-20 |
| TRANSQ3 (K001522) | Iomed, Inc. | 2000-10-18 |
| PHORESOR MODEL PM2000 (K001410) | Iomed, Inc. | 2000-08-01 |
| Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (K992874) | Wr Medical Electronics Co. | 1999-11-18 |
| PHORESOR II, MODEL PM900 (K974855) | Iomed, Inc. | 1998-03-27 |
| TRANSQ ELECTRODE PHORESOR II (K954126) | Iomed, Inc. | 1996-01-19 |
| WESCOR MODEL 3700 WEBSTER SWEAT INDUCER (K853973) | Wescor, Inc. | 1985-10-16 |
| SYS MACRODUCT SWEAT COLLECTION SYS 3600 (K840472) | Wescor, Inc. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |