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FDA 510(k)

MODEL TP THERMISTOR PROBE

K-Number: K831528 · 1983-06-30

ApplicantScimed Life Systems, Inc.
Decision Date1983-06-30
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL TP THERMISTOR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831528. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL TP THERMISTOR PROBE?

MODEL TP THERMISTOR PROBE is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K831528.

When did MODEL TP THERMISTOR PROBE receive FDA 510(k) clearance?

MODEL TP THERMISTOR PROBE received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831528.

Who is the listed applicant for MODEL TP THERMISTOR PROBE?

The FDA 510(k) record lists Scimed Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL TP THERMISTOR PROBE?

The FDA product code for MODEL TP THERMISTOR PROBE is DRF.

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Other records listing Scimed Life Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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