510(k) K062953
- Device
- MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
- Applicant
- MEDISYSTEMS CORP.
- 510(k) number
- K062953
- Product code
- FIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-12
- Date received
- 2006-09-29
- Regulation
- 876.5540
- Classification name
- Needle, Fistula
- 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
- FREDRIC SWINDLER
- Address
- 701 Pike St., Suite 1600 Seattle WA US 98101 98101
FDA Registration Numbers#
- 3000247873
- 3010413216
- 3010131137
- 3003895440
- 3032143970
- 9616419
- 3013671177
- 2029275
- 3013217742
- 3010187826
- 2028632
- 9615908
- 3003464075
- 8041145
- 2032098
- 3002807350
- 3010273867
Source Documents#
Other 510(k) Records For Product Code FIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025-08-15 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. | 2018-05-17 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-07-20 |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015-05-13 |
| K131950 | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | Summit International Medical Technologies, Inc. | 2015-01-16 |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | JMS North America Corporation | 2014-12-23 |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | Nxstage Medical, Inc. | 2014-09-11 |
| K112734 | APLAN A.V. FISTULA NEEDLE SET | Aplan Well Enterprise Co., Ltd. | 2012-04-24 |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | JMS North America Corporation | 2011-10-27 |
| K111948 | WINGEATER V2 | JMS North America Corporation | 2011-10-24 |
| K110157 | SYSLOC MINI V3 | JMS North America Corporation | 2011-02-11 |
| K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | Nipro Medical Corporation | 2010-03-17 |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | Jms North America Corp. | 2010-02-09 |
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2010-01-22 |
Legacy Summary#
summary
FDA Review#
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