Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE

K-Number: K870977 · 1987-04-01

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1987-04-01
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K870977. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE?

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K870977.

When did PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE receive FDA 510(k) clearance?

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870977.

Who is the listed applicant for PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE?

The FDA product code for PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE is KOD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Pharmaseal Div. Ahsc 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.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

View all 64 devices →

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑