510(k) K021580
- Device
- OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
- Applicant
- LeMaitre Vascular, Inc.
- 510(k) number
- K021580
- Product code
- LJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-12
- Date received
- 2002-05-14
- Regulation
- 880.5965
- Classification name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAMES ASHBY
- Address
- 26 Ray Ave. Burlington MA US 01803 01803
FDA Registration Numbers#
- 1000523114
- 3004407880
- 3013557562
- 1220905
- 1450392
- 3003700453
- 3003678543
- 1018233
- 9680794
- 3011534620
- 9617604
- 3008537309
- 9612452
- 1222928
- 2011171
- 3009746061
- 1061124
- 3013666218
- 1048735
- 3042205359
- 3012307300
- 3011088743
- 3006260740
- 3015531529
- 3010041511
- 3005232773
- 3010149039
- 3015537049
- 1319639
- 3007156625
- 3013750125
- 3007939342
- 9617592
- 9681202
- 1000393132
- 1223004
- 3015859709
- 3011237770
- 3018094310
- 2032112
- 2246552
- 1319211
- 3006082230
- 1820334
- 2030624
- 1219930
- 3003915875
- 8020785
- 3012494290
- 3006425876
- 2245270
- 3026560514
- 3006942524
- 3005704822
- 3009888344
- 2518902
- 9611665
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port | Bard Access Systems, Inc. | 2025-09-05 |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port | Bard Access Systems, Inc. | 2025-06-18 |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports | Bard Access Systems, Inc. | 2024-10-31 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port | Bard Peripheral Vascular, Inc. | 2023-12-08 |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020-05-22 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019-07-08 |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | 2016-06-06 |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | 2016-05-20 |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016-03-15 |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | 2015-11-20 |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | 2015-05-21 |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | 2015-05-01 |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | Cook Incorporated | 2014-05-21 |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | 2014-02-14 |