Telstar Prewire Series
FDA 510(k) K871731 · Telstar Electronics, Inc.
510(k) numberK871731
Submission
- Device name
- Telstar Prewire Series
- Applicant
- Telstar Electronics, Inc.
Longwood, FL, US - Received
- May 5, 1987
- Decision date
- October 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRS – I.V. Start Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…
Other 510(k)s with product code LRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050654 | Amsino I.V. Start KitLRS · Traditional | Amsino International, Inc. | 05/02/2005SE |
| K001879 | Infusion IV SetLRS · Traditional | Nirvi Intl. USA | 11/20/2001SE |
| K963722 | IV Start KitLRS · Traditional | Grand Medical Products | 11/27/1996SE |
| K951167 | EMS I.V. Start KitLRS · Traditional | Emergency Medical Supply, Inc. | 05/16/1995SN |
| K950184 | B. Braun IV Start KitsLRS · Traditional | B. Braun of America, Inc. | 03/15/1995SEKD |
| K944041 | Personal Hearing SystemLRS · Traditional | Resound Corp. | 12/27/1994SE |
| K943941 | Safestart Vascular Access Start KitLRS · Traditional | Becton Dickinson Vascular Access, Inc. | 10/20/1994SE |
| K935684 | IV Start KitLRS · Traditional | Cush Medical Products | 06/10/1994SEKD |
| K942238 | I.V. Startpak Vascular Access Start KitLRS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/03/1994SE |
| K941469 | IV Start KitLRS · Traditional | Clinical Resources, Inc. | 05/12/1994SE |
More from Clinical Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892460 | Telstar Model PP Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K892459 | Telstar Model C Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K892458 | Telstar Model F Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K892457 | Telstar Model 1/3 Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K873210 | Telstar Model PPESD · Traditional | 09/29/1987SE |
| K871520 | Telstar Model FS Hearing AidESD · Traditional | 06/08/1987SE |
| K871522 | Telstar Model C Hearing AidESD · Traditional | 06/05/1987SE |
| K871521 | Full Shell Ite Hearing AidESD · Traditional | 06/05/1987SE |
| K871518 | Telstar Model F3TS Hearing AidESD · Traditional | 06/05/1987SE |
| K871519 | Telstar Model 0/3 Hearing AidESD · Traditional | 05/19/1987SE |
Questions and answers
When was Telstar Prewire Series cleared by the FDA?
Telstar Prewire Series (K871731) received a 510(k) decision of Substantially Equivalent on October 27, 1987, 175 days after the submission was received.
What is the product code of K871731?
The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.