FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERMEDICS/GRASEBY DYNAMICS MS 36
K Number: K843331
·
Decision Nov 15, 1984
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
211
Review Days
80
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTERMEDICS/GRASEBY DYNAMICS MS 36
- K Number
- K843331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Intermedics, Inc.
- Date Received
- August 27, 1984
- Decision Date
- November 15, 1984
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Intermedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | Dec 16, 1996 | Substantially Equivalent - Subject to Tracking & PMS |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Nov 4, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | Aug 21, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | Jun 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | Jun 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Feb 27, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | Mar 15, 1995 | Substantially Equivalent |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | Apr 29, 1993 | Unknown |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | Jan 22, 1993 | Unknown |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | Mar 17, 1992 | Substantially Equivalent |