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Sign in to claim this brandAccess Scientific, Inc.
US
Last updated May 23, 2026
What Access Scientific, Inc. makes
Access Scientific, Inc. manufactures peripheral vascular catheters, vascular catheter introduction sets that are nonimplantable, and wearable percutaneous catheter/tube holders, including specific devices such as the CVC WAND, POWERWAND, PICC WAND, and POWERWAND™ XL.
The company's devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Access Scientific, Inc. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What medical devices does Access Scientific, Inc. manufacture?
Access Scientific, Inc. manufactures peripheral vascular catheters, vascular catheter introduction sets that are nonimplantable, and wearable percutaneous catheter/tube holders, including specific devices such as the CVC WAND, POWERWAND, PICC WAND, and POWERWAND™ XL.
Where is Access Scientific, Inc. based?
Access Scientific, Inc. is based in the United States, as indicated by the country information provided in the device data.
Which regulatory registries list Access Scientific, Inc.'s devices?
Access Scientific, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as specified in the device data information.
How are Access Scientific, Inc.'s devices classified?
Access Scientific, Inc.'s devices are regulated as Class I and Class II medical devices, as indicated in the device data classification information.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (53)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The CVC WAND Safety Introducer with Valved Peelable Sheath | K182243 | FDA 510(k) | Class II | Active |
| The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model | K183066 | FDA 510(k) | Class II | Active |
| The Power Wand Safety Introducer With An Extended Dwell Catheter | K101422 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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FDA Recalls (14)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Access Scientific, Inc. has 14 recall records initiated between 2013-08-16 and 2020-06-15, all with a status of terminated. The reasons for recall include mislabeled devices, compromised sterility due to packaging holes, and incorrect catheter effective length labeling on convenience kits.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 15, 2020 | Z-2550-2020 | — | terminated | Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance. |
| Apr 23, 2020 | Z-1974-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1979-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1976-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1981-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1973-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1978-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1983-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1977-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1982-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1980-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1972-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Apr 23, 2020 | Z-1975-2020 | — | terminated | Saline Flush Syringe compromised sterility due to holes in the packaging. |
| Aug 16, 2013 | Z-2254-2013 | — | terminated | Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. |