510(k) K960866
- Device
- LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
- Applicant
- LAKE REGION MFG., INC.
- 510(k) number
- K960866
- Product code
- KNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-05
- Date received
- 1996-03-04
- Regulation
- 876.5130
- Classification name
- Accessories, Catheter, G-u
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIM E AVES
- Address
- 340 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3005232773
- 9611590
- 3010155661
- 3009763019
- 2027111
- 1423537
- 3002807314
- 2022435
- 1625425
- 2020550
- 2032112
- 9612030
- 2029275
- 3010707607
- 1018233
- 3012322232
- 9681477
- 3010202439
- 1921846
- 9617594
- 3006174295
- 8010418
- 3016096097
- 3011050570
- 1713468
- 2126666
- 3003915875
- 9610617
- 3009051888
- 9680787
- 3004111573
- 3003790304
- 3016171914
- 2032098
- 3006082230
- 2183744
- 3014342096
- 2029015
Source Documents#
Other 510(k) Records For Product Code KNY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | 2017-03-02 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | 2014-06-16 |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2014-06-09 |
| K131803 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2013-08-20 |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | 2013-02-04 |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 |
| K062240 | CAREVENT | Chief Medical, LLC | 2006-10-16 |
| K052952 | CATHASSIST | Physician Technologies, Inc. | 2006-05-14 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | 2005-09-02 |
Legacy Summary#
summary
FDA Review#
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